The latest set of opinions from advisors to the European Medicines Agency has seen five innovative medicines recommended for approval.
The agency's Committee for Human Medicinal Products (CHMP) has issued a positive recommendation on Gilead Sciences' Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic hepatitis C in adults. It has also backed approval for ViiV Healthcare's HIV drug Tivicay (dolutegravir) in combination with other antiretrovirals.
The CHMP also recommended marketing authorisations for two tuberculosis medicines. First up is Otsuka Pharmaceutical Co's Deltyba (delamanid), which is recommended for the treatment of pulmonary infections due to multidrug-resistant tuberculosis, a reversal of the negative opinion issued in July after the company requested a re-examination. The other drug is Lucane Pharma of France’s para-aminosalicylic acid, called Lucane, for MDR-TB.
The EMA's advisors also backed Xigduo (dapagliflozin/metformin), a diabetes combo from AstraZeneca and Bristol-Myers Squibb.
Biogen's Tecfidera qualifies as new active substance
Among the other highlights from the CHMP meeting was the decision to update a previous opinion and agree that Biogen Idec's much-touted oral multiple sclerosis drug Tecfidera (dymethil fumarate) is qualified as a new active substance. A European launch has been delayed as the company sought assurances regarding data protection on the pill which is enjoying huge success in the USA and the CHMP's move gives Biogen 10 years' patent protection.
The CHMP also recommended adding the treatment of patients with metastatic pancreatic cancer to the approved indications for Celgene Corp's Abraxane (nab-paclitaxel) and backed label extensions for Boehringer Ingelheim's bloodthinner Pradaxa (dabigatran etexilate) and Johnson & Johnson's Velcade (bortezomib).
However, the committee adopted a negative opinion for AB Science's Masican (masitinib), which was intended for the treatment of gastrointestinal stromal tumour. The CHMP had concerns about the "exploratory nature of the study making it difficult to interpret the survival benefit, the limited sample size for safety and the uncertainties on impurities in manufacturing".