BioCryst Pharma (BCRX) Submits MAA for UK Approval of ORLADEYO, an Oral, Once-daily Therapy to Prevent Attacks in Patients with Hereditary Angioedema
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BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company 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 hereditary angioedema (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 February 25, 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,” said Jon Stonehouse, president and chief executive officer of BioCryst.
In October 2020, the MHRA granted ORLADEYO a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). Under the EAMS, HAE patients in the UK aged 12 years and older have access to ORLADEYO for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the MHRA.
In December 2020, the U.S. Food & Drug Administration (FDA) approved ORLADEYO in the U.S. In January 2021, ORLADEYO was approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
About ORLADEYO™ (berotralstat)
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
INDICATIONORLADEYO™ (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Limitations of useThe safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
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