The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.
The European Medicines Agency (EMA) announced during its November 2016 meeting that the agency’s Committee for Medicinal Products for Human Use (CHMP) was recommending nine drugs for approval. Three of the approved drugs were biosimilars: Lusduna (insulin glargine) for the treatment of diabetes, and Movymia and Terrosa (both containing teriparatide) for the treatment of osteoporosis. Generics Darunavir Mylan (darunavir), for the treatment of HIV-1, and Tadalafil Generics (tadalafil), for the treatment of pulmonary arterial hypertension were also approved.
Marketing authorization approval was also given to Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A; Vemlidy (tenofovir alafenamide) for the treatment of chronic hepatitis B; Fiasp (insulin aspart) for the treatment of diabetes; and Suliqua (insulin glargine/lixisenatide) for the treatment of type 2 diabetes.
Conditional marketing authorization was renewed for Translarna, a treatment for Duchenne muscular dystrophy. CHMP also recommended therapeutic indication extension for Arzerra, Caprelsa, Humira, Nimenrix, and Vimpat.
Source: EMA
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market
April 17th 2025Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.