Glaxo's Benlysta Gets Positive CHMP Opinion for Use in Kids
GlaxoSmithKline plc GSK announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") recommended approval for intravenous ("IV") formulation of Benlysta (belimumab) in children. The company is looking to get a nod for IV Benlysta as an add-on therapy for pediatric patients aged five years or older with active, autoantibody-positive systemic lupus erythematous ("SLE") with a high degree of disease activity.
The CHMP opinion will be now reviewed by the European Commission. A potential approval of IV Benlysta will make it the first therapy developed to treat this challenging autoimmune disease in children.
Notably, the FDA already approved an IV administration of Benlysta in pediatric patient population in April 2019. A subcutaneous formulation of Benlysta is already approved for the treatment of adult SLE patients in Europe as well as in the United States.
Glaxo’s stock has increased 8.9% so far this year compared with the industry’s rise of 0.5%.
The CHMP recommendation was based on data from a post-approval commitment study — PLUTO — which evaluated Benlysta in combination with the current standard-of-care. Data showed that children treated with Benlysta achieved a clinically meaningful improvement in disease activity at 52 weeks compared to placebo plus standard-of-care. Moreover, adverse events occurred in lower proportion of patients receiving Benlysta compared to placebo.
Systemic lupus erythematous is a chronic autoimmune disease, which is considered incurable and causes painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. SLE has been observed to be more active in children compared to adult patients. Per the press release, children aged from five to 17 years with SLE are estimated to be between 3,000 and 6,000 in Europe. Globally, SLE is the most common form of lupus disease affecting approximately 70% of the total five million of lupus patients.
Meanwhile, Glaxo is evaluating Benlysta combined with Roche’s RHHBY anti-CD20 monoclonal antibody Rituxan in a phase III study as a treatment for adult SLE patients. The company is trying to achieve clinical remission in patients.
Sales of Benlysta has increased 21% in the first six months of 2019. Label expansion of the drug in pediatric patients is likely to drives sales further.
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Zacks Rank & Stocks to Consider
Glaxo currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the large-cap pharma sector are Merck & Co. MRK and Eli Lilly LLY, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have been revised 3.8% upward for 2019 and 1.9% for 2020 in the past 30 days. The stock has rallied 11.4% so far this year.
Lilly’s earnings estimates have been revised 1.2% upward for 2019 and 0.6% for 2020 in the past 60 days.
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