Shares of biopharma Aimmune Therapeutics Inc (NASDAQ: AIMT) advanced strongly in after-hours trading Friday following a positive FDA verdict for Aimunne's peanut allergy drug.
9-Year Wait Ends
The FDA approved Palforzia allergen powder for treating patients with confirmed diagnosis of peanut allergy, the Brisbane, California-based company said in a late Friday release.
This is the first commercial success for the company, which was founded in 2011 and is working exclusively on therapies for food allergies.
An FDA panel, which reviewed the BLA for Palforzia back in September, voted 7-2, recommending the approval on the grounds of efficacy and safety.
Palforzia is an oral immunotherapy meant to mitigate allergic reactions, including anaphylaxis that may occur with accidental exposure to peanut.
The mechanism of action goes like this: the allergenic proteins are taken initially in small quantities, following by increasing amounts of ingestion, which helps mitigation of allergic reactions to the allergen over time.
Initial dose escalation may be administered to patients ages 4-17, and the updosing and maintenance could be continued in patients 4 and older, Aimmune said.
"This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families," CEO Jayson Dallas said in a statement.
Palforzia Ready For Launch
Aimmune said it is ready with a commercial field team that will coordinate with allergists to include it into their practices, adding that its payer team can immediately work toward gaining formulary access.
The company has set the list price of Palforzia at $890 per month, or $11,000 per year.
Aimmune is gearing to commercially launch the drug in one to weeks following the approval, CFO Eric Bjerkholt said in an interview to Benzinga late last year.
Peanut allergy, according to the company, affects more than 1.6 million children and teens in the U.S. It can be a chronic and life-long condition.
“We truly appreciate the efforts of the peanut allergy community who contributed to the development of PALFORZIA – including the more than 1,200 patients and their families who participated in our clinical trials, the study investigators and their staff, the advocacy community, and our dedicated employees – all of whom have helped us develop and deliver this first-of-its kind therapy,” Daniel Adelman, M.D., Aimmune's chief medical officer, said in a statement.
Rival Drug Waiting In The Wings
Bjerkholt defended his product by saying that Palforzia and DBV's Viaskin are two different products and there is room for more than one product.
"Against the threefold improvement for Viaskin patch, ours has shown a 100 times improvement in the median tolerated dose," he said.
Palforzia is available through a REMS, requiring the prescribing physician and patient to be enrolled in the REMS prior to initiation of treatment. The initial dose escalation and the first dose of each up-dosing are to be administered in a certified health care setting. Additionally, epinephrine must be always immediately available to patients.
The prescribing information comes with a boxed warning, as is with the case of approved immunotherapies indicated to treat allergic conditions, the company said.
In after-hours trading Friday, Aimmune shares rallied 16.55% to $36.19.
Photo courtesy of Aimmune.