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Pharmaceuticals / Submissions and Approvals / Commercial Operations

Anoro Gets Approval Nod From CHMP

Feb. 21, 2014

GlaxoSmithKline and Theravance’s lung drug Anoro inched another step closer to EU approval Thursday as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it a positive recommendation.

Anoro (umeclidinium/vilanterol) is a once-daily bronchodilator intended to treat patients with chronic obstructive pulmonary disease (COPD). CHMP’s positive opinion recommending the drug brings it one step closer to approval by the European Commission, which is expected in the second quarter of this year.

The drug, along with its inhaler Ellipta, received approval in the U.S. and Canada in December. The drug-device combo was also filed for approval in Japan back in April 2013 and is still under review there. — Ferdous Al-Faruque

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