Pfizer (PFE) Gets FDA Nod for Growth Hormone Deficiency Drug
Pfizer PFE along with partner OPKO Health OPK announced that the FDA has approved Ngenla (somatrogon) as a once-weekly treatment for pediatric patients aged three years and older with growth hormone deficiency (“GHD”).
GHD or pituitary dwarfism is a rare disease caused by genetic mutations or acquired after birth. It is marked by inadequate secretion of growth hormones from the pituitary gland, affecting a child’s height and even delaying puberty. Management estimates that one out of 4,000-10,000 children is affected by the disease.
The FDA’s approval is based on data from a phase III study, which evaluated once-weekly Ngenla against Genotropin (somatropin), a standard-of-care drug that is administered once-daily. The study achieved its primary endpoint of Ngenla, demonstrating non-inferiority against somatropin, as measured by the annual height velocity at 12 months.
Pfizer expects the drug’s commercial launch in the United States this August. The drug is already approved in more than 40 countries, including Australia, Canada, Japan and European countries.
Year to date, Pfizer’s shares have lost 29.2% against the industry’s 0.8% growth.
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Pfizer entered into a collaboration with OPKO Health in 2014 to develop and market Ngenla. Per the agreement, Pfizer is responsible for the commercialization of the drug and OPKO Health is accountable for the drug’s clinical development.
Following this approval, Pfizer/OPKO Health’s Ngenla can compete with rival drugs Skytrofa and Sogroya that are currently being marketed by Ascendis Pharma ASND and Novo Nordisk NVO, respectively. All these drugs are approved as once-weekly treatments for pediatric GHD. The Ngenla approval will also reduce pressure on Pfizer whose Genotropin sales have started to experience a decline since there are multiple drugs approved for treating GHD and only require once-weekly administration.
Ascendis Pharma’s Skytrofa (lonapegsomatropin) was approved by the FDA in 2021 to treat GHD in individuals aged one year and older who weigh at least 11.5 kg (25.4 lbs). Following the approval, Skytrofa became the first FDA-approved once-weekly therapy for pediatric GHD and Ascendis Pharma’s first ever marketed product. In January 2022, Ascendis announced that Skytrofa secured approval in the European Union for use in children aged three through 18 years.
Earlier this April, Novo Nordisk announced that the FDA approved the label expansion for its GHD drug Sogroya (somapacitan) to treat GHD in children aged 2.5 years and older. Last month, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (“CHMP”) recommended approval for a label expansion filing of the drug for use in children aged three years and older. The Novo Nordisk drug was initially approved in the United States and European Union in 2020 and 2021, respectively, to treat GHD in adults.
Since the onset of this year, Pfizer received multiple FDA approvals for existing and new products and therapies. Last week, the agency granted label expansion approvals to Litfulo and Talzenna for treating alopecia areata in adolescents and certain adult patients with prostate cancer. Pfizer’s RSV vaccine Abrysvo was also approved for use in older adults by the FDA last month. In March, the agency approved the company’s migraine nasal spray, Zavzpret, for use in adults. These approvals are likely to boost the company’s top line, which has been suffering a plunge due to fall in demand for COVID-19 products.
In the next 18 months, Pfizer expects to launch up to 19 new products or indications (all non-COVID indications), which are expected to generate around $20 billion of sales by 2030. Per management, two-thirds of these products have blockbuster potential.
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Pfizer 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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