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
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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