BioCryst Pharmaceuticals, Inc. has submitted a marketing authorization application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval of Orladeyo (berotralstat) for the prevention of recurrent HAE attacks in HAE patients 12 years and older. The MAA was submitted under the MHRA’s new European Commission Decision Reliance Procedure (ECDRP).
On 25 February 2021, BioCryst announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion recommending the approval of Orladeyo for routine prevention of recurrent attacks of HAE in adult and adolescent patients aged 12 years and older. The European Commission (EC) will review the CHMP recommendation and a final approval decision from the EC on the marketing authorization application for Orladeyo is expected in the second quarter.
When a valid ECDRP submission is made within five days of a CHMP positive opinion, the date of the CHMP positive opinion will be designated Day 0 of the ECDRP, and the MHRA will aim to determine the Great Britain MAA as soon as possible following submission of confirmation of the EC decision.
If approved, Orladeyo would be the first oral, once-daily therapy in the United Kingdom to treat patients with HAE.
“The ECDRP provides an opportunity to accelerate the approval of Orladeyo in the UK following approval by the European Commission. If approved, Orladeyo will provide a much needed oral, once-daily option for many patients and we are excited to be a step closer to making this a reality for them,” says Jon Stonehouse, President and CEO of BioCryst.