EMA announces medicine approval recommendations from November meeting

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has announced the results of its November 2019 meeting, recommending seven medicines for approval. The committee suggested granting a marketing authorisation for Isturisa (osilodrostat), a treatment for Cushing’s syndrome, a disorder that occurs when the body produces too much corticosteroid hormone. Mayzent (siponimod), for the treatment of adult patients with secondary progressive multiple sclerosis and Sunosi (solriamfetol), for the treatment of excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnoea, both received a positive opinion from the committee. Tavlesse (fostamatinib) also received a positive opinion from the CHMP to treat primary immune thrombocytopenia, an acquired immune-mediated disorder characterised by the destruction of platelets and impaired platelet production. A conditional marketing authorisation was recommended for Polivy (polatuzumab vedotin) indicated for relapsed/refractory diffuse large B-cell lymphoma.