EU agency backs respiratory drugs for approval

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[February 24, 2014]  LONDON (Reuters) European regulators recommended the approval of a clutch of drugs to treat respiratory diseases on Friday, including two from GlaxoSmithKline and another from Teva Pharmaceuticals.

The European Medicines Agency (EMA) said four of the drugs recommended for approval were intended to treat the symptoms of chronic obstructive pulmonary disease (COPD), a condition that typically affects smokers, while another two were for asthma and COPD.

Israeli drugmaker Teva received the nod for a combination of budesonide and formoterol, delivered by its Spiromax multi-dose dry powder inhaler, for the regular treatment of asthma and for the symptomatic treatment of patients with severe COPD.

The fixed dose combination of the drugs, which have an anti-inflammatory effect in the lungs and which open the airways, was submitted under the names BiResp Spiromax and DuoResp Spiromax.

A combination of umeclidinium bromide and vilanterol, developed by GSK and Theravance, was also recommended for approval under the brands Anoro and Laventair.

GSK, a leader in respiratory medicine, also received the green light for umeclidinium as a monotherapy, which it will market as Incruse. The company released details of the judgments on Thursday.

A dual-action drug from Novartis, which was authorized last year, also received the green light for a new marketing authorization under the Ulunar Breezhaler name, the EMA said, while Pfizer's neuropathic pain, epilepsy and generalized anxiety disorder drug Pregabalin was also recommended on the same basis.

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In other therapy areas, Vokanamet, a treatment for type 2 diabetes from Johnson & Johnson, was given the nod.

Recommendations for approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

(Reporting by Paul Sandle; editing by Sarah Young and David Holmes)

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