Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
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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Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn.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.
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 | CHMP 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 | CHMP 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 | CHMP 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 | CHMP 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 | CHMP 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 | CHMP 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 | CHMP post-authorisation summary of positive opinion for Adcetris |
| Name of medicine | Humira |
|---|---|
| INN | adalimumab |
| Marketing-authorisation holder | AbbVie Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Humira |
| Name of medicine | Kyprolis |
|---|---|
| INN | carfilzomib |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Kyprolis |
| Name of medicine | Revestive |
|---|---|
| INN | teduglutide |
| Marketing-authorisation holder | NPS Pharma Holdings Limited |
| More information | CHMP post-authorisation summary of positive opinion for Revestive |
| Name of medicine | Simponi |
|---|---|
| INN | golimumab |
| Marketing-authorisation holder | Janssen Biologics B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Simponi |
| Name of medicine | Tysabri |
|---|---|
| INN | natalizumab |
| Marketing-authorisation holder | Biogen Idec Ltd |
| More information | CHMP post-authorisation summary of positive 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 (sirolimus) |
| Name of medicine | Xegafri |
|---|---|
| INN | rociletinib |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Xegafri (rociletinib) |
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