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

News 27/05/2016

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

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Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn.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

CHMP highlights - May 2016

Positive recommendations on new medicines

Name of medicine	Epclusa
INN	sofosbuvir / velpatasvir
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Treatment of chronic hepatitis C
More information	Summary of opinion for Epclusa Press release: Two new combination therapies against chronic hepatitis C

Name of medicine	Qtern
INN	saxagliptin / dapagliflozin
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Treatment of type 2 diabetes mellitus
More information	Summary of opinion for Qtern

Name of medicine	Zepatier
INN	elbasvir / grazoprevir
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
Therapeutic indication	Treatment of chronic hepatitis C
More information	Summary of opinion for Zepatier Press release: Two new combination therapies against chronic hepatitis C

Negative recommendation on new medicine

Name of medicine	Ninlaro
INN	ixazomib
Marketing-authorisation applicant	Takeda Pharma A/S
Therapeutic indication	Treatment of multiple myeloma
More information	Questions and answers on refusal of the marketing authorisation for Ninlaro

Positive recommendations on new generic medicines

Name of medicine	Bortezomib Hospira
INN	bortezomib
Marketing-authorisation applicant	Hospira UK Limited
Therapeutic indication	Treatment of multiple myeloma and mantle cell lymphoma
More information	Summary of opinion for Bortezomib Hospira

Name of medicine	Bortezomib Sun
INN	bortezomib
Marketing-authorisation applicant	Sun Pharmaceutical Industries (Europe) B.V.
Therapeutic indication	Treatment of multiple myeloma and mantle cell lymphoma
More information	Summary of opinion for Bortezomib Sun

Name of medicine	Pemetrexed Fresenius Kabi
INN	pemetrexed
Marketing-authorisation applicant	Fresenius Kabi Oncology PLC
Therapeutic indication	Treatment of unresectable malignant pleural mesothelioma and non-small cell lung cancer
More information	Summary of opinion for Pemetrexed Fresenius Kabi

Positive recommendations on extensions of therapeutic indications

Name of medicine	Adcetris
INN	brentuximab vedotin
Marketing-authorisation holder	Takeda Pharma A/S
More information	Summary of opinion for Adcetris

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd
More information	Summary of opinion for Humira

Name of medicine	Kyprolis
INN	carfilzomib
Marketing-authorisation holder	Amgen Europe B.V.
More information	Summary of opinion for Kyprolis

Name of medicine	Revestive
INN	teduglutide
Marketing-authorisation holder	NPS Pharma Holdings Limited
More information	Summary of opinion for Revestive

Name of medicine	Simponi
INN	golimumab
Marketing-authorisation holder	Janssen Biologics B.V.
More information	Summary of opinion for Simponi

Name of medicine	Tysabri
INN	natalizumab
Marketing-authorisation holder	Biogen Idec Ltd
More information	Summary of opinion for Tysabri

Outcome of arbitration procedure

Name of medicine	Levonelle 1500mcg tablets and associated names
INN	levonorgestrel
Marketing-authorisation holder	Gedeon Richter Plcv Group of companies
More information	Levonelle 1500 microgram tablets and associated names