EU Agency backs respiratory drugs for approval

EU Agency backs respiratory drugs for approval

LONDON (Reuters) – European regulators recommended the approval of a clutch of drugs to treat respiratory diseases on Friday, including two from GlaxoSmithKline & 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 & COPD.

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

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

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

GSK, a leader in respiratory medicine, moreover 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, moreover received the green light for a new marketing authorization under the Ulunar Breezhaler name, the EMA said, while Pfizer's neuropathic pain, epilepsy & generalized anxiety disorder drug Pregabalin was moreover 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.

(Reporting by Paul Sandle; Editing by Sarah Young & David Holmes)

HealthPharmaceuticals & Drug TrialsEuropean Medicines AgencyTeva Pharmaceuticalsrespiratory diseases

Source: “Reuters”

Share and Enjoy

  • Facebook
  • Twitter
  • Delicious
  • LinkedIn
  • StumbleUpon
  • Add to favorites
  • Email
  • RSS