2024-03-07 15:24:00
Sanofi challenged in UK for treatment of sphingomyelinase deficiency
The agency responsible for recommendations in England and Wales, NICE (National Institute for Health and Care Excellence) has decided not to recommend Xenpozyme (olipudase alfa), the treatment for Sanofi for acid sphingomyelinase deficiency, a product already approved in Europe and the United States. The organization motivated its decision by uncertainties regarding the economic model, with a cost/effectiveness balance deemed to exceed its standards.
Sanofi deplores this decision by mentioning “devastating news for patients and those around them”while treatment for this very rare disease, which affects around 40 people in the United Kingdom, is particularly accessible in Ireland and Scotland.
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A new treatment for ulcerative colitis, Velsipity from Pfizer, approved in Europe
The EMA has authorized the marketing of Velsipity (etrasimod) Pfizer in the treatment of moderate to severe ulcerative colitis, following conclusive phase III results. The tablet is to date the only medication administered orally to treat this pathology and can be prescribed if traditional treatment fails.
Already approved in October 2023 by the FDA, its approval in Europe represents significant hope for the 280,000 people affected in France.
Sandoz authorized by the FDA to market two biosimilars
Denosumab, an antibodyAmgenis marketed under two distinct brands, Prolia and Xgeva. Sandoz has just obtained FDA approval to market the biosimilars Jubbonti and Wyost, with indications identical to the reference products, namely osteoporosis and bone cancer respectively. The launch schedule for the two drugs has not yet been communicated by Sandoz, which is in dispute with Amgen over patents.
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