LONDON Feb 21 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
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
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
A dual-action drug from Novartis, which was
authorised last year, also received the green light for a new
marketing authorisation under the Ulunar Breezhaler name, the
EMA said, while Pfizer's neuropathic pain, epilepsy and
generalised anxiety disorder drug Pregabalin was also
recommended on the same basis.
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.