EMA Backs Six Drugs, One Biosimilar for EU Approval

Regulatory News

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

The six medicines the agency is recommending are:

• Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation;
• Merck Sharp & Dohme's Prevymis (letermovir) to prevent infections in patients who receive stem cell transpants. Prevymis was also granted orphan designation;
• Roche's Ocrevus (ocrelizumab) to treat relapsing multiple sclerosis and early primary progressive multiple sclerosis;
• Baxalta's Adynovi (rurioctocog alfa pegol) to prevent bleeding in patients 12 and older with hemophilia A;
• AstraZeneca's Fasenra (benralizumab) to treat severe eosinophilic asthma; and
• Endoceutics' Intrarosa (prasterone) to treat vulvar and vaginal atrophy in postmenopausal women.

CHMP also recommended Amgen's Mvasi (bevacizumab) biosimilar for Roche's Avastin (bevacizumab). Amgen had originally submitted two marketing authorization applications for Avastin biosimilars, but in October the company withdrew its application for the other biosimilar "for marketing reasons."

Additionally, CHMP recommended two generics for Janssen's HIV drug Prezista (darunavir) both made by Slovenia-based Krka, and Mylan's generic of AstraZeneca's breast cancer drug Faslodex (fulvestrant).

CHMP also said that it is maintaining its negative opinion for two drugs, Fanaptum (iloperidone) and Onzeald (etirinotecan pegol), following requests from the drugs' sponsors to re-examine the committee's earlier decision.

EMA