CHMP News - May 2016


Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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).

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.

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Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn.

PRIME statistics

The first statistics on the PRIME (PRIority MEdicines) scheme, launched to enhance support for the development of medicines that target an unmet medical need, will be released on 1 June 2016 on EMA's website, and then each month on the Wednesday following the CHMP meeting as part of the annexes in the CHMP highlights.

More information on CHMP's May 2016 meeting can be found here.