LONDON, Feb 21 (Reuters) - European regulators recommendedthe approval of a clutch of drugs to treat respiratory diseaseson Friday, including two from GlaxoSmithKline andanother from Teva Pharmaceuticals.
The European Medicines Agency (EMA) said four of the drugsrecommended for approval were intended to treat the symptoms ofchronic obstructive pulmonary disease (COPD), a condition thattypically affects smokers, while another two were for asthma andCOPD.
Israeli drugmaker Teva received the nod for a combination ofbudesonide and formoterol, delivered by its Spiromax multi-dosedry powder inhaler, for the regular treatment of asthma and forthe symptomatic treatment of patients with severe COPD.
The fixed dose combination of the drugs, which have ananti-inflammatory effect in the lungs and which open theairways, was submitted under the names BiResp Spiromax andDuoResp Spiromax.
A combination of umeclidinium bromide and vilanterol,developed by GSK and Theravance, was also recommendedfor approval under the brands Anoro and Laventair.
GSK, a leader in respiratory medicine, also received thegreen light for umeclidinium as a monotherapy, which it willmarket as Incruse. The company released details of the judgmentson Thursday.
A dual-action drug from Novartis, which wasauthorised last year, also received the green light for a newmarketing authorisation under the Ulunar Breezhaler name, theEMA said, while Pfizer's neuropathic pain, epilepsy andgeneralised anxiety disorder drug Pregabalin was alsorecommended on the same basis.
In other therapy areas, Vokanamet, a treatment for type 2diabetes from Johnson & Johnson, was given the nod.
Recommendations for approval by the EMA's Committee forMedicinal Products for Human Use (CHMP) are normally endorsed bythe European Commission within a couple of months.
Glaxosmithkline (GSK)
