The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its May meeting.
The CHMP recommended granting marketing authorisations in the European Union for two new combination therapies to treat chronic (long-term) hepatitis C, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir). For more information please see the press release in the grid below.
Qtern (saxagliptin / dapagliflozin) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.
Three generic medicines received a positive opinion from the Committee: Bortezomib Hospira (bortezomib) and Bortezomib Sun (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma, and Pemetrexed Fresenius Kabi (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.
Negative opinion on new medicine
The CHMP adopted a negative opinion for Ninlaro (ixazomib). Ninlaro was expected to be used for treating multiple myeloma in adults who had received at least one prior treatment. For more information, please see the questions-and-answers document in the grid below.
Request for re-examination of CHMP recommendation
The applicant for Sialanar (glycopyrronium bromide) has requested a re-examination of the CHMP’s negative opinion for this medicine adopted at the April 2016 meeting. The CHMP will now re-examine this opinion and issue a final opinion.
Six recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Adcetris, Humira,Kyprolis, Revestive, Simponi and Tysabri.
Withdrawals of applications
Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.