Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014
Six new medicines recommended for approval
The Committee gave a positive recommendation for Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Adempas has an orphan designation.
The Committee recommended the granting of a marketing authorisation for Latuda (lurasidone) for the treatment of schizophrenia.
The Committee gave a positive recommendation for Bemfola (follitropin alfa), a new biosimilar medicine for the treatment of infertility.
Two generic medicines were also recommended for approval by the CHMP: Rivastigmine 3M Health Care Ltd for the treatment of Alzheimer's dementia and Zoledronic acid Teva Generics for the treatment of osteoporosis and Paget's disease of the bone.
Positive scientific opinion on Hemoprostol
The CHMP also recommended the approval of Hemoprostol (misoprostol), indicated for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available. Hemoprostol will be intended exclusively for markets outside the European Union.
Four negative opinions on new medicines
The Committee adopted four negative opinions in January 2014, including opinions for Nerventra, which was intended for the treatment of multiple sclerosis and Reasanz, which was intended for the treatment of acute heart failure. The Committee also issued negative opinions for two orphan medicines, Masiviera which was intended for the treatment of non resectable locally advanced or metastatic pancreatic cancer and Translarna which was intended for the treatment of Duchenne muscular dystrophy.
Three recommendations on extensions of therapeutic indications
Review of emergency contraceptives started
The CHMP started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or contraceptive failure. Please see press release Review of emergency contraceptives started for more details.
Update on safety review of Protelos / Osseor
The recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that Protelos and Osseor should no longer be used to treat osteoporosis is still under consideration by the CHMP. At its January 2014 meeting the Committee requested additional information from the company to inform its scientific decision-making. A final opinion will be made by the CHMP at its meeting in February 2014.
The marketing authorisation holder for Linoladiol N and Linoladiol HN has requested a re-examination of the CHMP's December 2013 opinion on Linoladiol N. Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine its opinion and issue a final opinion.
The CHMP has recommended lifting the suspension of the marketing authorisation for Vibativ. The Committee recommended suspending the marketing authorisation for the medicine in 2012 following a Good Manufacturing Practice (GMP) inspection of Ben Venue Laboratories, Ohio, USA, which was triggered by shortcomings in quality assurance identified at this site. At its January 2014 meeting, the CHMP was of the opinion that the marketing authorisation holder has provided sufficient evidence to confirm that a suitable manufacturing site has been approved and therefore recommended lifting the suspension. The suspension of the marketing authorisation for Luminity, which was also suspended in 2012 following the same inspection, was lifted at the CHMP meeting in December 2013.
Agenda and minutes
The agenda of the January 2014 meeting is published on the EMA web site. The minutes of the meeting will be published during the week following the February CHMP meeting. Minutes of the December 2013 CHMP meeting will be published next week.
Positive recommendations on new medicines
|Name of medicine||Adempas|
|International non-proprietary name (INN)||riociguat|
|Marketing-authorisation applicant||Bayer Pharma AG|
|Therapeutic indication||Treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension|
|More information||Summary of opinion for Adempas|
|Name of medicine||Eperzan|
|Marketing-authorisation applicant||GlaxoSmithKline Trading Services|
|Therapeutic indication||Treatment of type 2 diabetes mellitus|
|More information||Summary of opinion for Eperzan|
|Name of medicine||Hemoprostol|
|Marketing-authorisation applicant||Linepharma France|
|Therapeutic indication||Indicated in women of childbearing age for treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available|
|More information||Summary of opinion for Hemoprostol submitted under Article 58 for use outside the European Union|
|Name of medicine||Latuda|
|Marketing-authorisation applicant||Takeda Pharma A/S|
|Therapeutic indication||Treatment of schizophrenia|
|More information||Summary of opinion Latuda|
Negative recommendations on new medicines
|Name of medicine||Masiviera|
|Marketing-authorisation applicant||AB Science|
|Therapeutic indication||Treatment of non resectable locally advanced or metastatic pancreatic cancer|
|More information||Questions and answers on refusal of the marketing authorisation for Masiviera|
|Name of medicine||Nerventra|
|Marketing-authorisation applicant||Teva Pharma GmbH|
|Therapeutic indication||Treatment of multiple sclerosis|
|More information||Questions and answers on refusal of the marketing authorisation for Nerventra|
|Name of medicine||Reasanz|
|Marketing-authorisation applicant||Novartis Europharm Ltd|
|Therapeutic indication||Treatment of acute heart failure|
|More information||Questions and answers on refusal of the marketing authorisation for Reasanz|
|Name of medicine||Translarna|
|Marketing-authorisation applicant||PTC Therapeutics Limited|
|Therapeutic indication||Treatment of Duchenne muscular dystrophy|
|More information||Questions and answers on refusal of the marketing authorisation for Translarna|
Positive recommendation on new biosimilar medicine
|Name of medicine||Bemfola|
|Marketing-authorisation applicant||Finox Biotech AG|
|Therapeutic indication||Treatment of infertility|
|More information||Summary of opinion for Bemfola|
Positive recommendations on new generic medicines
|Name of medicine||Rivastigmine 3M Health Care Ltd|
|Marketing-authorisation applicant||3M Health Care Ltd|
|Therapeutic indication||Treatment of Alzheimer's dementia|
|More information||Summary of opinion for Rivastigmine 3M Health Care Ltd|
|Name of medicine||Zoledronic acid Teva Generics|
|Marketing-authorisation applicant||Teva Generics B.V.|
|Therapeutic indication||Treatment of osteoporosis and Paget's disease of the bone|
|More information||Summary of opinion for Zoledronic acid Teva Generics|
Positive recommendations on extensions of therapeutic indications
|Name of medicine||NovoThirteen|
|Marketing-authorisation holder||Novo Nordisk A/S|
|More information||Summary of opinion for NovoThirteen|
|Name of medicine||Stelara|
|Marketing-authorisation holder||Janssen-Cilag International N.V.|
|More information||Summary of opinion for Stelara|
|Name of medicine||Xolair|
|Marketing-authorisation holder||Novartis Europharm Ltd|
|More information||Summary of opinion for Xolair|
Outcome of harmonisation procedure
|Name of medicine||Rocephin|
|Marketing-authorisation holder||Roche group of companies|
Withdrawal of application
|Name of medicine||Winfuran|
|Marketing-authorisation holder||Toray International U.K. Limited|
|More information||Winfuran: Withdrawn application|