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The Committee for Medicinal Products for Human Use (CHMP) held a meeting on Jan. 20-23, 2014.
The Committee for Medicinal Products for Human Use (CHMP) held a meeting on Jan. 20 - 23, 2014. Six new medicines were recommended for approval: Eperzan (albiglutide), for the treatment of type 2 diabetes; Adempas (riociguat), for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension; Latuda (lurasidone) for the treatment of schizophrenia; Bemfola (follitropin alfa), a new biosimilar medicine for the treatment of infertility; 3M's generic version of rivastigmine for the treatment of Alzheimer's dementia and Teva's generic version of zoledronic acid for the treatment of osteoporosis and Paget's disease of the bone.
The Committee also adopted a positive opinion on Hemoprostol (misoprostol) for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available. Hemoprostol was recommended for approval and will be intended exclusively for markets outside the European Union.
The following four new medicines received negative opinions: Nerventra for the treatment of multiple sclerosis; Reasanz for the treatment of acute heart failure; and two orphan drugs, Masiviera for the treatment of non resectable locally advanced or metastatic pancreatic cancer and Translarna for the treatment of Duchenne muscular dystrophy.
The CHMP recommended extensions of indications for NovoThirteen, Stelara and Xolair.
The Committee also started a review on 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. New data suggest that a high bodyweight could impair the effectiveness of emergency contraceptives. EMA will assess whether any changes should be made to the product information for all emergency contraceptive medicines containing levonorgestrel or ulipristal acetate. More details can be found here.
CHMP has not reached a decision regarding the use of Protelos and Osseor for the treatment of osteoporosis. The Pharmacovigilance Risk Assessment Committee (PRAC) recommended that Protelos and Osseor should not be used to treat osteoporosis. CHMP has requested additional information from the company and announced that a final opinion will be made at its February meeting.
CHMP will re-examine its opinion on Linoladiol N and Linoladiol HN as requested from the marketing authorization holder. A final opinion will be issued after re-examination.
The CHMP has recommended lifting the suspension of the marketing authorization for Vibativ. The marketing authorization for Vibativ was suspended in 2012 following a GMP inspection of Ben Venue Laboratories, Ohio, USA. Quality assurance issues were identified at the site. The Committee is convinced that the marketing authorization holder has given enough evidence to confirm that the site is suitable for manufacturing and has, therefore, recommended lifting the suspension. The suspension of the marketing authorization for Luminity, which was also suspended in 2012 following the same inspection, was lifted at the CHMP meeting in December 2013.
Key figures from the January 2014 meeting can be found here. EMA will provide cumulative figures in the CHMP highlights every month.