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Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infants

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First and only single-dose RSV preventative option approved for broad newborn and infant population.
European Commission grants first approval worldwide following positive CHMP opinion in September.

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.1 Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two.2,3

The European Commission is the first regulatory body to grant approval to Beyfortus.1 The approval was based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials,1,4-11and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.12

In the pivotal MELODY efficacy trial, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% (95% CI 49.6, 87.1; p<0.001) vs. placebo through day 151 (a typical RSV season) with a single dose.1,4-9 Beyfortus also demonstrated a comparable safety and tolerability profile to Synagis (palivizumab) in the MEDLEY Phase II/III trial, with occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) similar between groups.1,10-13

Silke Mader, Chairwoman of the Executive Board and Co-founder of the European Foundation for the Care of Newborn Infants (EFCNI), said: “Respiratory syncytial virus represents a health threat among infants, and each year we see the impact it can have on families, healthcare providers and the healthcare system. At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV.”

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “Beyfortus is the first single-dose preventative option against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. Today’s marketing authorisation of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention.”

Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, said: “Today is a landmark day for RSV prevention, as decades of research and development come together in the world’s first approval of a broadly protective option against respiratory syncytial virus disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season.”

RSV is the most common cause of LRTI, including bronchiolitis and pneumonia in infants.14 It is also a leading cause of hospitalisation in all infants.15-18 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.19 RSV-related direct medical costs, globally – including hospital, outpatient and follow-up care – were estimated at €4.82 billion in 2017.21

Notes

Beyfortus
Beyfortus (nirsevimab), a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by AstraZeneca and Sanofi using AstraZeneca’s YTE technology.

Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.20

Beyfortus has been granted marketing authorisation in the European Union for the prevention of RSV LRTI disease in newborns and infants from birth during their first RSV season. The recommended dose of Beyfortus is a single intramuscular injection of 50 mg for infants with body weight <5 kg and a single intramuscular injection of 100 mg for infants with body weight ≥5 kg.12

Beyfortus has also been granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA PRIority Medicines (PRIME) scheme; and named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). The safety and efficacy of Beyfortus was evaluated under an accelerated assessment procedure by the EMA.

Pivotal clinical trials

The Phase IIb study was a randomised, placebo-controlled trial designed to measure the efficacy of Beyfortus (nirsevimab) against medically attended LRTI through 150 days postdose. Healthy preterm infants of 29–35 weeks’ gestation were randomised (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo.1,4,5

The dosing regimen was recommended based on further exploration of the Phase IIb data. The subsequent Phase III study, MELODY applied the recommended dosing regimen.1,3,6

The MELODY Phase III study was a randomised, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.1-3

MEDLEY was a Phase II/III, randomised, double-blind, Synagis-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive Synagis.1,8,9 Between July 2019 and May 2021 approximately 918 infants entering their first RSV season were randomised to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of Beyfortus or Synagis. Safety was assessed by monitoring the occurrence of TEAEs and TESAEs through 360 days post-dose.1,8,9 Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the MELODY Phase III trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely. Data was published in the New England Journal of Medicine (NEJM) in March 2022.

The results of MELODY, MEDLEY Phase II/III and the Phase IIb trials demonstrate that Beyfortus helps protect infants during their first RSV season against RSV disease with a single dose.1-9 This all-infant population includes preterm, healthy late preterm and term infants, as well as infants with specific conditions.

These trials form the basis of regulatory submissions which began in 2022.

Results from the Phase IIb trial

The primary endpoint of the Phase IIb study was met, reducing the incidence of medically attended LRTI, caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo. Between November 2016 and December 2017, 1,453 infants were randomised (Beyfortus, n=969; placebo, n=484) at the RSV season start. Research was conducted by AstraZeneca in both hemispheres, at 164 sites in 23 countries.1,4,5 Data was published in NEJM in July 2020.

Data were imputed for participants who had no events and were not followed through 150 days postdose. Analyses were conducted using Poisson regression with robust variance. CI, confidence interval; ITT, intent-to-treat; LRTI, lower respiratory tract infection; RRR, relative risk reduction; RSV, respiratory syncytial virus.

 

Results from the MELODY Phase III trial

The primary endpoint of the MELODY Phase III trial was met, reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. Infants were randomised (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of Beyfortus or placebo. Between July 2019 and March 2020, 1,490 infants were randomised to either Beyfortus or placebo at the RSV season start.1-3 Data was published in NEJM in March 2022.

Data were imputed for participants who had no events and were not followed through 150 days postdose. Analyses were conducted using Poisson regression with robust variance. CI, confidence interval; ITT, intent-to-treat; LRTI, lower respiratory tract infection; RRR, relative risk reduction; RSV, respiratory syncytial virus.

 

Results from the pre-specified pooled analysis of the Phase IIb and MELODY trials

A prespecified pooled analysis of the MELODY Phase III trial and the recommended dose from the Phase IIb trial, in which an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.1,8 The pooled analysis studied healthy preterm and term infants who received the recommended dose of Beyfortus based on weight compared to placebo through Day 151 and showed an efficacy of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalisations.1,4,8

Medically Attended LRTI and Hospitalisation for RSV LRTI Through 150 Days Postdose (ITT population)

Data were imputed for participants who had no events and were not followed through 150 days postdose. Analyses were conducted using Poisson regression with robust variance. CI, confidence interval; ITT, intent-to-treat; LRTI, lower respiratory tract infection; RRR, relative risk reduction; RSV, respiratory syncytial virus.

Sanofi Alliance

In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi leads commercialisation activities and records revenue. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Company’s financial statements.

Sobi agreement

Related, in November 2018, AstraZeneca agreed to sell US commercial rights for Synagis (palivizumab) to Swedish Orphan Biovitrum AB (publ) (Sobi) in addition to the right to participate in payments that may be received by AstraZeneca from the US profits or losses for nirsevimab. Under the agreement AstraZeneca received upfront consideration and also received non-contingent payments for nirsevimab during 2019-2021. AstraZeneca is also entitled to receive certain milestone payments for nirsevimab, including a $175m milestone following the date on which the Biologics License Application (BLA) for nirsevimab is accepted for filing by the FDA and a $90m milestone payment following the date on which BLA approval in the US occurs. AstraZeneca will continue to manufacture and supply nirsevimab globally and is entitled to an additional royalty from Sobi if profits from nirsevimab in the US exceed a pre-specified level.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts

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References

  1. European Commission. https://ec.europa.eu/transparency/documentsregister/detail?ref=C(2022)7992&lang=enAccessed November 2022
  2. Glezen WP et al. Am J Dis Child. 1986;140(6):543-5463.
  3. Collins et al. Journal of Virology. 2008:2040–2055.
  4. Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late -Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.
  5. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed September 2022.
  6. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://www.clinicaltrials.gov/ct2/show/NCT02878330 . Accessed September 2022.
  7. Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556.
  8. Simões, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
  9. Wilkins, D, et al. Nirsevimab for the prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
  10. Domachowske J, MD et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022; 386 (9).
  11. Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). Accessed September 2022.
  12. European Medicines Agency. Beyfortus Summary of Committee for Medicinal Products for Human Use Opinion Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/beyfortus. Accessed September 2022.
  13. Synagis – Summary of Product Characteristics (SmPC) – (eMC) [Internet]. Available from: https://www.medicines.org.uk/emc/product/6963/smpc Accessed September 2022.
  14. R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkin’s Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.
  15. Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.
  16. McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.
  17. Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.
  18. Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595
  19. Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:92047–64.
  20. Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed September 2022.
  21. Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687.
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Nordea Bank Abp: Återköp av egna aktier den 05.12.2022

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Nordea Bank Abp
Börsmeddelande – Förändringar i återköpta aktier
05.12.2022 kl. 22.30 EET

Nordea Bank Abp (LEI-kod: 529900ODI3047E2LIV03) har den 05.12.2022 slutfört återköp av egna aktier (ISIN-kod: FI4000297767) enligt följande:

Handelsplats (MIC-kod)

Antal aktier

Viktad snittkurs/aktie, euro*, **

Kostnad, euro*, **

XHEL

260 000

 10,10

2 626 052,00

CEUX

240 000

 10,08

2 420 336,96

TQEX

36 000

 10,08

 362 819,55

XSTO

240 000

 10,07

2 416 602,28

XCSE

28 000

 10,10

 282 816,90

Summa

 804 000

 10,09

8 108 627,70

* Växelkurser som använts: SEK till EUR 10,9185 och DKK till EUR 7,4371
** Avrundat till två decimaler

Den 18 juli 2022 tillkännagav Nordea ett program för återköp av egna aktier till ett värde av högst 1,5 md euro med stöd av det bemyndigande som gavs av Nordeas ordinarie bolagsstämma 2022. Återköpet av egna aktier utförs genom offentlig handel i enlighet med Europaparlamentets och rådets förordning (EU) nr 596/2014 av den 16 april 2014 (marknadsmissbruksförordningen) och Kommissionens delegerade förordning (EU) 2016/1052.

Efter de redovisade transaktionerna innehar Nordea 11 832 125 egna aktier för kapitaloptimeringsändamål och 6 073 651 egna aktier för ersättningsändamål.

Uppgifter om respektive transaktion finns som en bilaga till detta meddelande.

För Nordea Bank Abp:s räkning,
Citigroup Global Markets Europe AG

För ytterligare information:

Matti Ahokas, chef för investerarrelationer, +358 9 5300 8011
Group Communication, +358 10 416 8023 eller [email protected]

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”Insikter om hot och våld” Del 2: Ett nytt, hårdare samtalsklimat

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Vad som många har en diffus känsla av stämmer – samtalsklimatet mellan medborgare och samhällets företrädare HAR blivit hårdare. Detta är ett vetenskapligt belagt faktum och det finns en tydlig koppling till hur samtalstonen på nätet har utvecklats. 

Måns Svensson är professor i rättssociologi, vilket förenklat kan beskrivas som kunskapen om hur sociala normer samspelar med lagstiftningen. Under senare tid har Svensson forskat kring utvecklingen av näthat och hur det påverkat kommunikationen mellan allmänhet och olika samhällsföreträdare, exempelvis förtroendevalda, journalister, lärare och vårdanställda.  

– Den här typen av ogillande som samhällets representanter utsätts för visar att den sociala kontrollen har förändrats i grunden, vilket är ett resultat av hur vi kommunicerar online. Vi har tillgång till varandra och kan uttrycka ogillande på ett sätt som är helt nytt. 

Intervjun med Måns Svensson är del två i Säker Vårdmiljös intervjuserie ”Insikter om hot och våld”. Seriens ambition är att lyfta fram insikter, perspektiv och lärdomar på ett ämne som tyvärr blir alltmer aktuellt.  

Du hittar filmerna i serien här:
https://vimeo.com/showcase/9940451

Säker Vårdmiljö startar under hösten även ett kunskapsnätverk som fokuserar på problematiken med hot och våld. Intresserad? Anmäl dig här. 

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Återköp av aktier i MTG under vecka 48, 2022

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Från 28 november till 2 december 2022 har Modern Times Group MTG AB (publ) (LEI-kod 549300E8NDODRSX29339) (“MTG”) återköpt sammanlagt 166 437 egna aktier av serie B (ISIN-kod: SE0018012494) inom ramen för det återköpsprogram som styrelsen infört i syfte att leverera värde till bolagets aktieägare och optimera kapitalstrukturen.

Återköpen är en del av det återköpsprogram om maximalt 4 618 818 aktier till ett sammanlagt belopp om högst 400 miljoner kronor som MTG tillkännagav den 25 oktober 2022. Återköpsprogrammet löper från den 27 oktober 2022 och fram till årsstämman 2023 och genomförs i enlighet med EU:s Marknadsmissbruksförordning (EU) nr 596/2014 (”MAR”) och Kommissionens delegerade förordning (EU) nr 2016/1052 (”Safe harbour-förordningen”). Syftet med återköpsprogrammet är att leverera värde till aktieägare och att optimera kapitalstrukturen. Avsikten är att MTG:s aktiekapital ska nedsättas genom en indragning av återköpta aktier.

Aktier av serie B i MTG har återköpts (i kronor) enligt följande:

Datum Aggregerad daglig volym (antal aktier) Viktat genomsnittspris per dag (SEK) Totalt dagligt transaktionsvärde (SEK)
2022-11-28 35 587 83,0867 2 956 806,39
2022-11-29 35 000 83,0586 2 907 051,00
2022-11-30 33 851 82,3301 2 786 956,22
2022-12-01 35 149 82,8424 2 911 827,52
2022-12-02 26 850 83,7622 2 249 015,07

Samtliga förvärv har genomförts på Nasdaq Stockholm av Nordea Bank Abp för MTG:s räkning. Efter ovanstående förvärv uppgår MTG:s innehav av egna aktier per den 2 december 2022 till 3 347 283 aktier av serie B och 6 324 343 aktier av serie C. Det totala antalet aktier i MTG uppgår till 134 035 940.

Fullständig information om de genomförda transaktionerna enligt artikel 5.3 i MAR och artikel 2.3 i Safe harbour-förordningen biläggs detta pressmeddelande.

För mer information:

Anton Gourman, VP Communications and IR
Direkt: +46 73 661 8488, 
[email protected]

Följ oss: mtg.com / Twitter / LinkedIn

Om MTG

MTG (Modern Times Group MTG AB (publ.)) (www.mtg.com) är en internationell mobilspelskoncern som äger och driver spelutvecklare med globalt populära titlar som sträcker sig över en bred uppsättning genrer inom casual- och mid-core-spel. Koncernen fokuserar på att accelerera portföljbolagens tillväxt och stödja grundare och entreprenörer. MTG är en aktiv aktör i den pågående konsolideringen av spelindustrin och en strategisk köpare av gamingbolag världen runt. Vi kommer från Sverige men har en internationell kultur och globalt fotavtryck. Våra aktier är noterade på Nasdaq Stockholm under symbolerna MTGA och MTGB.

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