GlaxoSmithKline plc GSK announced that the FDA has granted approval to Nucala as an add-on treatment for severe eosinophilic asthma in the pediatric patient population, aged six to 11 years, in the United States. The drug is already marketed in the United States and EU for severe eosinophilic asthma patients aged 12 years or older. In the EU, it had received approval for pediatric use (from aged six-17 years) in August last year.
The supplemental Biologics License Application seeking label expansion of Nucala for pediatric use was based on data from a pediatric open-label study, which evaluated Nucala for pharmacokinetics, pharmacodynamics and long-term safety in patients aged six to 11 years.
So far this year, Glaxo’s shares have outperformed the industry, rising 7.4% against the industry’s 1.2% decrease.
Nucala is also approved for treating eosinophilic granulomatosis with polyangiitis and is in late-stage development for nasal polyps. Earlier this year, two new self-administered options for Nucala, an auto injector and a pre-filled safety syringe, to be taken once every four weeks, were approved in the United States and EU.
Nucala is a key drug in Glaxo’s portfolio of new respiratory drugs. Sales of Nucala were more than $447 million in the first half of 2019, registering growth of around 37% at constant exchange rate. The FDA approval for pediatric patients broadens the drug’s eligible patient population and can boost sales in the future quarters.
However, competitive pressure in respiratory market has risen with the launch of AstraZeneca’s AZN Fasenra and Sanofi SNY/Regeneron Pharmaceuticals’ REGN Dupixent. Notably, Dupixent is also being evaluated in phase III studies for pediatric asthma.
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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