EMA Advisory Committee Recommends 15 New Medicines for Approval

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 10-01-2014 05:04

Fifteen new medicines have been recommended for approval at the September meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee recommended a marketing authorization for Gilead Sciences' Harvoni (sofosbuvir / ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. 

Laboratoire HRA Pharma's Ketoconazole HRA (ketoconazole) was recommended by the CHMP as a new treatment for patients with Cushing’s syndrome. Pharmacological options for this condition remain very limited and there is an unmet medical need for additional medicines. Ketoconazole HRA has an orphan designation. 

Two medicines were recommended for approval by the CHMP for the treatment of cancer: Boehringer Ingelheim's Vargatef (nintedanib) for the treatment of non-small cell lung cancer and Eli Lilly's orphan medicine Cyramza (ramucirumab) for the treatment of gastric cancer. The diagnostic agent Lymphoseek (tilmanocept) from Navidea Biopharmaceuticals was also recommended for the delineation and localization of sentinel lymph nodes.

Teva's Egranli (balugrastim) was recommended by the CHMP for the treatment of chemotherapy-induced neutropenia and Janssen-Cilag's Rezolsta (darunavir / cobicistat) received a positive opinion for the treatment of human immunodeficiency virus (HIV).

The CHMP also recommended Eli Lilly's Trulicity (dulaglutide) for the treatment of Type 2 diabetes and AstraZeneca's Moventig (naloxegol) for the treatment of opioid-induced constipation.

The generic medicine Tadalafil Mylan was recommended by the Committee for the treatment of erectile dysfunction in adult males.

The CHMP granted positive opinions for  two Almirall's medicines Brimica Genuair and Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorizations of both medicines.

Three hybrid applications, all from Teva, received positive recommendations from the Committee: 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. The active ingredients in these medicines are budesonide and formoterol. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Source: EMA 

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