Novartis receives CHMP backing for Sebri Breezhaler
26 June 2012 11:24 in Pharmaceutical Company Product News
Novartis has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for its new chronic obstructive pulmonary disease (COPD) treatment Seebri Breezhaler.
The therapy has been endorsed for European Medicines Agency approval as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult COPD patients.
Results taken from three phase III trials of Sebri Breezhaler that demonstrated its safety and efficacy benefits compared to placebo and alternative treatments supported this recommendation.
A final decision from the European Commission is expected within three months, while a US filing of the product will take place in 2014.
David Epstein, division head of Novartis Pharmaceuticals, said: "Seebri Breezhaler will be the second innovative once-daily inhaled treatment ... delivered using the low-resistance Breezhaler device that allows patients to hear, feel and see that they have taken the drug correctly."
This comes in the same week that the company also received a CHMP recommendation for approval of Afinitor as a breast cancer therapy.
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