March EMA/CHMP meeting backs Rubraca and Juluca, as well as biosimilars and generics

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.

The CHMP recommended granting a conditional marketing authorization for Rubraca (rucaparib), from Clovis Oncology (Nasdaq: CLVS), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development.

Juluca (dolutegravir/rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection. The applicant ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline (LSE: GSK). The drug is recommended for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The two-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC).