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Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn.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

CHMP_highlights_May_2016.png

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


Withdrawals of initial marketing authorisation applications

Name of medicine

Opsiria

INN

sirolimus

More information

Questions and answers on the withdrawal of the marketing authorisation application for Opsiria

Name of medicine

Xegafri

INN

rociletinib

More information

Questions and answers on the withdrawal of the marketing authorisation application for Xegafri

Other updates

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • Start of Community reviews
  • Guidelines and concept papers adopted
  • Organisational matters
  • Opinions on consultation procedures on ancillary medicinal substances in medical devices


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

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