tis, jul 07, 2020 11:00 CET

EVENITY® (romosozumab), ett nytt läkemedel för behandling av osteoporos, ingår i högkostnadsskyddet med viss begränsning utifrån godkänd indikation meddelar TLV i sitt beslut. ¹

Sverige 7 juli 2020 – Tandvårds- och läkemedelsförmånsverket (TLV) har beslutat att EVENITY® (romosozumab) ska ingå i högkostnadsskyddet från och med den 3 juli 2020. Sedan tidigare har EVENITY® blivit godkänt av europeiska läkemedelsmyndigheten, EMA, för behandling av svår osteoporos hos postmenopausala kvinnor med hög risk för fraktur. EVENITY® är ett nytt benbyggande läkemedel som både ökar benbildning och minskar benresorption (benförlust).

TLV:s beslut om subvention, med viss begränsning utifrån godkänd indikation, innebär att EVENITY® endast subventioneras vid behandling av osteoporos hos postmenopausala kvinnor som haft en klinisk kotfraktur eller en höftfraktur de senaste tolv månaderna.¹

Subventionsbeslutet baseras på data från ARCH-studien (Active-contRolled FraCture Study in Postmenopausal Women With Osteoporosis at High Risk of Fracture) som visade att en sekventiell behandling med EVENITY® följt av alendronat signifikant minskade frakturer än behandling enbart med alendronat.² TLV konstaterar att det är kostnadseffektivt att behandla kvinnor som haft en klinisk kotfraktur eller höftfraktur de senaste 12 månaderna med EVENITY® först istället för att starta med standard of care. Kostnaden för behandling med EVENITY® för den utvärderade patientpopulationen, postmenopausala kvinnor med osteoporos som haft en klinisk kotfraktur eller en höftfraktur de senaste tolv månaderna, bedöms som rimlig i förhållande till den nytta läkemedlet ger.¹

Osteoporos är en kostsam folksjukdom som ökar risken för frakturer. En halv miljon svenskar är drabbade och varje år sker det ca 80 000 – 90 000 osteoporosrelaterade frakturer. Cirka 50 procent av alla kvinnor beräknas få benskörhetsfrakturer under sin livstid.³ Eftersom befolkningen lever allt längre kommer antalet troligtvis att öka. Trots detta får endast 17 procent av kvinnorna över 50 år i Sverige med osteoporos behandling.⁴

Referenser

1. TLVs beslut om EVENITY®, Läs beslutet i sin helhet på www.tlv.se.

2. Saag KG, et al. N Engl J Med 2017;377:1417-1427.

3. Socialstyrelsen (2020) Nationella riktlinjer för rörelseorganens sjukdomar

4. IOF, Brutna ben, trasiga liv. En åtgärdsplan får att låsa krisen med trasiga liv 2019; https://share.iofbonehealth.org/EU-6-Material/Repor…

Presskontakt:

Estelle Bajtner, medicinsk chef osteoporos UCB Norra Europa
estelle.bajtner@ucb.com
0730-73 59 43

Patric Berling, VD UCB Sverige
patric.berling@ucb.com
070-552 90 98

About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. 

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of the acquisition of Otezla^® (apremilast), including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the European Medicines Agency, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

SE-N-RM-OP-2000019 07.06.2020