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EU: Fifteen medicines leap toward EU approval


(Source: Pharma Times 2014-10-01)

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended a stream of new products for approval within the region, with a group of 15 now having jumped the final hurdle before an ultimate decision from regulators.

First up, Gilead’s Harvoni (sofosbuvir/ledipasvir) has been backed for clearance to treat adults with hepatitis C (HCV). The drug belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates, and marks the third new therapy for the disease put forward by the CMHP in the last few months.

Next, Laboratoire HRA Pharma’s Ketoconazole HRA (ketoconazole) has been recommended as a ‘new’ treatment for patients with the rare hormonal disorder Cushing’s syndrome. The drug, normally used to fight fungal infections (though no longer by mouth because of liver injury risk), has actually been used off-label to treat Cushing’s for more than 30 years, but it has never been formally approved for this indication.

Two cancer drugs have also won CHMP backing - Boehringer Ingelheim’s Vargatef (nintedanib) for the treatment of non-small cell lung cancer and Eli Lilly’s Cyramza (ramucirumab) for gastric cancer. The diagnostic agent Lymphoseek (tilmanocept) was also endorsed for the delineation and localisation of sentinel lymph nodes.

According to BI, Vargatef, when added to docetaxel, is the first lung cancer treatment to have provided over one-year overall survival for patients with advanced adenocarcinoma, after first-line chemotherapy. And with regard to Lilly’s biologic Cyramza, clinical data show that adding the drug to paclitaxel significantly boosted median overall survival in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma.

Elsewhere, the CHMP also recommended: Teva Pharma’s Egranli (balugrastim) for chemotherapy-induced neutropenia, as well as the firm’s Brimica Genuair and Duaklir Genuair (aclidinium/formoterol fumarate dihydrate) for maintenance bronchodilator treatments to relieve symptoms of chronic obstructive pulmonary disease and asthma; Janssen-Cilag’s Rezolsta (darunavir/cobicistat) for human immunodeficiency virus (HIV); Eli Lilly’s Trulicity (dulaglutide) for type II diabetes; AstraZeneca’s Moventig (naloxegol) for opioid-induced constipation; and Generics (UK)’s generic Tadalafil Mylan for erectile dysfunction in adult males.

Three hybrid applications have also received the thumbs up: Budesonide/Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD, and Budesonide/Formoterol Teva Pharma B.V. for the treatment of asthma. Hybrid applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data, the Committee said.

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