Pfizer, Inc. (PFE Quick QuotePFE - Free Report) along with partner OPKO Health announced that the FDA has accepted the biologics license application (BLA) for somatrogon, its long-acting, once-weekly therapy to treat pediatric patients with growth hormone deficiency (GHD). The BLA was granted standard review and the FDA’s decision is expected in October 2021.

The BLA filing is based on data from a phase III study evaluating somatrogon dosed once-weekly in children with GHD. The study met its primary endpoint by showing non-inferiority of somatrogon injection compared to its own medicine Genotropin/somatropin injection (current standard of care) administered once daily, as measured by annual height velocity at 12 months. The top-line data showed that the least square mean was higher in the somatrogon group versus the somatropin group.

The efficacy of somatrogon seen in the study demonstrates its potential to reduce the current dosing frequency from once-daily to a single weekly injection.

Pfizer’s shares have declined 5.7% in the past year against the industry’s 3.6% increase.

Pfizer and OPKO signed the global deal for somatrogon in 2014, per which OPKO is mainly responsible for clinical development while Pfizer will take care of commercializing the product.

GHD is a rare disease characterized by insufficient secretion of somatropin, the hormone that causes growth, from the pituitary gland. Owing to this an individual’s height may remain short in adulthood and cause other health problems as well. Presently available treatments for GHD are Novo Nordisk’s (NVO Quick QuoteNVO - Free Report) Norditropin, Roche’s (RHHBY Quick QuoteRHHBY - Free Report) Nutropin and Lilly’s (LLY Quick QuoteLLY - Free Report) Humatrope, among others.

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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