CHMP Recommends Six Medicines for Approval in EU

The Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval during its May 2016 meeting, according to an EMA press announcement. The CHMP recommended granting market authorization for two new combination therapies to treat chronic (long-term) hepatitis C, Epclusa (sofosbuvir / velpatasvir) and Zepatier (grazoprevir / elbasvir). Qtern (saxagliptin / dapagliflozin), a treatment for Type 2 diabetes mellitus, also received a positive opinion from the committee.

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 were recommended for approval. The committee also adopted a positive opinion of Pemetrexed Fresenius Kabi (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer. 

In a press announcement, the committee said it had adopted a negative opinion for Ninlaro (ixazomib), a drug intended to treat multiple myeloma in adults who had received at least one prior treatment.  In a report, the CHMP said, “the data in the subgroups was not compelling enough and the rationale for assuming greater effectiveness in these patients was not clear.” Ultimately, the committee said they found the data “insufficient” to demonstrate a benefit of Ninlaro in the treatment of multiple myeloma.

Source: EMA