ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant Merck & Co’s Biologic License Application (BLA) for the investigational grass sublingual allergy immunotherapy (AIT) tablet on Thursday.

Denmark-based allergy specialist ALK Abello (ALKB: DC) became the first pharma victim of the US government shutdown in October when the meeting for its tablet, under development with Merck, its partner for North America, was delayed.

At the meeting, for which Alk-Abello says FDA staffers have released positive briefing papers, the committee will be asked whether the available data support the safety and the efficacy of the product (marketed in Europe as Grazax) in persons of five years of age and older. In addressing this question, the Committee should address safety and efficacy for adult and paediatric patients separately. It will also discuss recommendations regarding the need, if any, for additional trials.