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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016

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

London, UK (May 27, 2016) – 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Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn.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.

PRIME statistics

The first statistics on PRIME will be released on Wednesday 1 June, and then each month on the Wednesday following the CHMP meeting as part of the annexes in the CHMP highlights.

Agenda and minutes

The agenda of the May 2016 meeting is published on EMA’s website. Minutes of the April 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the May 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s May 2016 meeting, is available in the grid below.

Positive recommendations on new medicines

Negative recommendation on new medicine

Positive recommendations on new generic medicines

Positive recommendations on extensions of therapeutic indications

Outcome of arbitration procedure

Withdrawals of initial marketing authorisation applications

Other updates

European Medicines Agency (EMA), 27.05.2016 (tB).