Regulatory Focus™ > News Articles > FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies

FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies

Posted 21 November 2016 | By Zachary Brennan 

FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies

The US Food and Drug Administration’s (FDA) Office of Compliance in Biologics Quality in the Center for Biologics Evaluation and Research (CBER) on Monday released an untitled letter sent to Cambridge, MA-based Antera Therapeutics because it's selling an unapproved biologic intended to prevent a peanut allergy.

According to the letter dated 16 November to Antera CEO Clarence Friedman, a Harvard Business School graduate in 2015 and former senior associate scientist at Pfizer, FDA says the company’s website makes unsubstantiated claims about its “all-natural formula that makes giving peanut protein to your child safe and easy.”

Among other issues, the site highlights that the product, known as Aralyte, has been manufactured, packaged and stored “to be maximally effective in allergy prevention and with your family’s safety in mind.”

A three-month supply of Aralyte costs $180.

“The Aralyte daily regiment was crafted to be a precise amount of exposure to the allergen, keeping your baby safe,” the website reads.

“Based on these claims, it appears your product is intended to prevent a peanut allergy from developing in children, and therefore appears to be a drug,” FDA said, noting the biologic has not been approved by the agency for safety or effectiveness. “Your product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect for the use of this product. Based on this information, we have determined that your actions have violated the FFD&C [Federal Food, Drugs and Cosmetics] Act and PHS [Public Health Service] Act.”

Antera has yet to respond to a request for comment. In June, the company raised $1.7 million in seed funding from RA Capital Management.

Separately on Monday, CBER also released an untitled letter to the CEO of Flushing, NY-based Assured Bites, which offers a similar product intended to prevent a peanut allergy that FDA says is an unapproved biologic.

Untitled Letter


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