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The Guardian - UK
The Guardian - UK
Business
Nick Fletcher

GlaxoSmithKline lifted as US regulators recommend approval of pulmonary treatment Anoro

GlaxoSmithKline has been having a hard time of it recently, but there is finally some good news for the company.

After bribery allegations in China and a disappointing trial result for cancer treatment Mage-A3 came reports this week that generic competition to its best selling lung drug Advair was a step closer.

But now the US Food and Drug Administration has voted that Glaxo's pulmonary disease treatment Anoro showed sufficient efficacy and safety to justify approval. The final decision is expected on 18 December. Analysts at JP Morgan said:

We believe Anoro approval may be caveated with: (1) Cautions against use in patients with severe cardiovascular disease, and (2) A requirement for a post-marketing study, potentially including a broader patient population.

We currently model peak Anoro sales of £1.5bn, 20%-30% ahead of consensus, though US Anoro expectations will have risen post Friday's benign AdCom briefing docs.

We believe the positive Anoro panel vote has the potential to drive some US Anoro upgrades, which could partly offset cuts to US Advair post 2016.

Glaxo shares have edged up 1p to 1599.5p in a downbeat market.

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