Aimmune Therapeutics, the biopharmaceutical company whose Palforzia oral immunotherapy treatment for peanut allergy was approved by the FDA in January, warned on Monday that its marketing plans for the treatment will be curtailed due to the social distancing response to the coronavirus.
The FDA requires physicians to undergo the Palforzia Risk Evaluation and Mitigation Strategies (REMS) program before they may begin prescribing the therapy in their practices. Admission of pharmaceutical representatives to hospitals is likely to be restricted and physicians may avoid training events until the virus threat has abated.
Aimmune has warned that it has had to postpone in-person workshops to train physicians and that its representatives may not be able to support certain clinics that administer the Palforzia therapy. The company hopes to keep its launch on-track via virtual workshops and web conferences.
With manufacturing is based entirely in the US, Aimmune said it remains fully operational and has sufficient stock on hand to meet demand for the foreseeable future.