GlaxoSmithKline GSK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of two newself-administered options for its asthma drug, Nucala (mepolizumab). The EMA recommended two new methods for administering the drug — a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks — to patients with severe eosinophils asthma.
The CHMP opinion is supported by positive data from two phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in clinic and at home by asthma patients or their caregivers. Both the studies showed that after appropriate training, the patients were able to successfully self-administer the treatment with both the pre-filled pen and pre-filled safety syringe. Another single-dose pharmacokinetic and pharmacodynamic study (NCT03014674) showed that the profile of Nucala administered via the syringe/pen option was comparable to the originally approved lyophilised formulation.
We remind investors that Nucala is approved for severe eosinophilic asthma patients aged 12 years or olderin the United States. Asupplemental biologics license application (sBLA) is under review with the FDA,seeking label expansion in pediatric patients (aged six to 11 years) in the United States. In the EU, it received approval for pediatric use (from aged six-17 years) in August 2018.
The company is also developing the drug in additional indications. A phase III study is currently evaluating Nucala in patients with nasal polyps. A potential approval in pediatric asthma patients and successful development in other indications will further boost the prospects of the drug, driving the company’s top line.
Nucala sales surged 41% in the first quarter of 2019, supported by its global rollout.
Meanwhile, Regeneron Pharmaceuticals, Inc. REGN and its partner Sanofi SNY received approval for Dupixent in October 2018 as an add-on maintenance therapy for treating moderate-to-severe asthma with an eosinophilic phenotype. This is likely to intensify competitive pressure on Nucala. Notably, the companies are also developing Dupixent in pediatric patients. In March 2019, EMA's CHMP gave a positive opinion for Dupixent in asthma.
AstraZeneca AZN is also evaluating tezepelumab for the treatment of asthma, which is currently in phase III studies.
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