The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Sanofi (SNYNF) and Regeneron’s Dupixent (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE).
Breakthrough Therapy designation is designed to expedite the development and review of drugs in the U.S. that target serious or life-threatening conditions.
There are currently no FDA-approved medicines for EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. Over time, excessive type 2 inflammation causes scarring and narrowing of the esophagus, making it difficult to swallow and eat.
In the U.S. alone, there are approximately 160,000 patients with EoE who are currently being treated with various unapproved therapies or diet modification. Of these patients, approximately 50,000 have failed multiple treatments.
Sanofi and Regeneron (REGN) previously reported positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients 12 years and older with EoE. Part A of the randomized, double-blind, placebo-controlled trial of 81 patients met both of its co-primary endpoints, as well as all key secondary endpoints.
Patients treated weekly with Dupixent 300 mg over a 24-week treatment period experienced a reduction in symptoms, esophageal inflammation and abnormal endoscopic findings in the esophagus.
Part A of the trial also demonstrated safety results consistent with the known safety profile of Dupixent in its approved indications. The EoE trial is ongoing, with additional patients enrolling in Part B as well as patients continuing in a 28-week extended active treatment period (Part C) after completing either Part A or Part B.
In 2017, Dupixent also was granted Orphan Drug designation for the potential treatment of EoE. This is given to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.
Shares in REGN have surged 45% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s with an average analyst price target of $661, indicating 21% further upside potential lies ahead.
“REGN is on the cusp of: (1) strong 20/21 sales growth, (2) increased Eylea penetration in DME in 2020/21; (3) approval, launch, and fast uptake of Dupixent in asthma/other allergic conditions; and (4) approval, launch, and fast uptake of Libtayo in advanced cSCC/other oncology indications” commented Oppenheimer’s Hartaj Singh recently.
He has a buy rating on the stock, adding “we continue to believe investors should own the three leaders (respectively) in the COVID-19 race; GILD, REGN, and MRNA.” (See REGN stock analysis on TipRanks).
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