Regeneron REGN announced that the FDA has approved a 300-mg, single-dose, pre-filled pen for asthma drug, Dupixent (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration. This new pre-filled pen will provide patients with a more convenient option for administering Dupixent and be available from the third quarter.
Meanwhile, Regeneron and partner Sanofi SNY are working with the FDA to provide additional data they require to complete their review of the 200 mg pre-filled pen.
Additionally, both companies announced that the National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The approval was based on positive data from the global LIBERTY AD clinical study that included nearly 3,000 patients with inadequately controlled moderate-to-severe atopic dermatitis. The trials evaluated Dupixent (monotherapy or in combination with topical corticosteroids) on safety and efficacy measures, including skin clearance, overall disease severity and itch.
We remind investors that Dupixent is currently approved in the United States, Europe, Japan and other countries for the treatment of moderate-to-severe atopic dermatitis, as well as asthma or chronic rhinosinusitis with nasal polyposis (CRSwNP) in patients from different age populations.
Dupixent sales came in at $855.2 million in the first quarter of 2020. Label expansions in additional geographies should further boost sales.
The companies are further evaluating Dupixent in a comprehensive program for various indications, including pediatric asthma (6 to 11 years of age, phase III), pediatric atopic dermatitis (6 months to 5 years of age, phase II/III), eosinophilic esophagitis (phase III), chronic obstructive pulmonary disease (phase III), bullous pemphigoid (phase III), prurigo nodularis (phase III), chronic spontaneous urticaria (phase III), and food and environmental allergies (phase III).
Regeneron’s share price has surged 71.5% in the year so far compared with 13.3% growth for the industry.
The company has had a great year so far, soaring high and pioneering the race for a possible coronavirus treatment along with other biotechs like Gilead Sciences, Inc. GILD.
Regeneron recently initiated the first study on its experimental dual antibody cocktail, REGN-COV2, for the prevention and treatment of COVID-19.
This program consists of four separate study populations — hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected patients in groups that are at high risk of exposure (such as healthcare workers or first responders) and uninfected patients with close exposure to a COVID-19 patient (such as the patient's housemate).
Concurrently, the company is working to diversify its pipeline. It expanded its existing collaboration with Intellia Therapeutics, Inc. NTLA. Per the terms, the companies will co-develop potential hemophilia A and B treatments using their jointly-owned targeted transgene insertion capabilities.
Regeneron 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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