(Source: PharmaTimes 2014-3-25)
The latest set of opinions from advisors to the European Medicines Agency include recommendations to approve nine new medicines, including potential blockbuster offerings in diabetes and hepatitis C, plus a drug for a sub-type of ovarian cancer and the first medicine for Castlemans disease.
Nine new medicines have been backed by the agencys Committee for Medicinal Products for Human Use (CHMP). First up, it has issued a positive opinion for a conditional approval of Merck & Co/Endocytes Vynfinit (vintafolide) for the treatment of women with a sub-type of platinum-resistant ovarian cancer for which there are limited approved treatment options. The CHMP has also recommended two Vynfinit companion diagnostic medicines, Folcepri (etarfolatide) and Neocepri (folic acid) that will help identify patients who may benefit from the drug.
The CHMP has also backed Janssens Sylvant (siltuximab) for patients with multicentric Castleman’s disease following an accelerated assessment. It is a rare disorder characterised by non-cancerous growth of the lymph nodes and related tissues.
For diabetes, the committee recommended marketing authorisation for Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin), a member of the new sodium glucose co-transporter-2 (SGLT2) inhibitor class. The backing comes a few weeks after the US Food and Drug Administration turned down the drug over deficiencies at the facility where it will be produced.
The EMAs advisors also gave a positive recommendation for Takedas Entyvio (vedolizumab) for the treatment of ulcerative colitis and Crohn’s disease and gave their support to Johnson & Johnsons Olysio (simeprevir) for chronic hepatitis C in combination with other drugs.
GlaxoSmithKlines Revinty Ellipta (fluticasone/vilanterol) for the treatment of asthma and chronic obstructive pulmonary disease was also recommended for approval, as was Actavis Ebilfumin (oseltamivir), a generic of Roches Tamiflu.
The CHMP also recommended extensions of indications for Roches hepatitis drug Pegasys (peginterferon alfa-2a) and Novo Nordisks diabetes drugs Victoza (liraglutide) and Tresiba (insulin degludec).
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