The latest set of opinions from advisors to the European Medicines Agency sees seven new medicines recommended for approval.
Most notably, the agency's Committee for Human Medicinal Products (CHMP) has issued a positive recommendation on Celgene Corp's pomalidomide, already marketed as Pomalyst in the USA, for the treatment of multiple myeloma. Specifically, the drug has been backed in combination with dexamethasone in patients who have received at least two prior therapies, including both Celgene's own Revlimid (lenalidomide) and Takeda and Johnson & Johnson's Velcade (bortezomib), and have demonstrated disease progression while on their last therapy.
The CHMP has also recommended approval of Bavarian Nordic's modified vaccinia Ankara (MVA) smallpox vaccine, marketed outside the European Union as Imvamune, under exceptional circumstances. It also backed Teva's Lonquex (lipegfilgrastim) for the reduction of neutropenia and CSL Behring's Voncento for the prevention of bleeding in von Willebrand disease and haemophilia A (ie congenital factor VIII deficiency).
Aegerion Pharmaceuticals' Lojuxta (loitapide) received a positive opinion for the treatment of homozygous familial hypercholesterolaemia, in addition to a low fat diet and other lipid-lowerers. It also backed Somatropin Biopartners (somatropin), made by German firm BioPartners, as a replacement therapy for endogenous growth hormone deficiency and Sun Pharmaceutical Industries' Atosiban Sun, a generic of Ferring's Tractocile, for the delay of imminent pre-term birth in pregnant adult women.
Other highlights of the meeting saw the CHMP recommend extending the indications for Novartis' cancer therapy Glivec (imatinib) and its eye drug Lucentis (ranibizumab), Pfizer's childhood vaccine Prevenar 13 and the multiple sclerosis drug Tysabri (atalizumab), for which Elan has sold the full rights to partner Biogen Idec.