BioCryst expects EU review of Orladeyo very soon

“With two approvals for Orladeyo, our launch in the U.S., and the addition of more than 425 million USD through our May and December financings, 2020 was a transformational year,” Jon Stonehouse, President and CEO says at the presentation of the BioCryst Pharmaceuticals, Inc. financial results for the fourth quarter and full year ended 31 December 2020. “Using our strong balance sheet as a foundation, we expect to continue this transformation in 2021 with Orladeyo generating revenue in the U.S., Japan and Europe”.

Orladeyo (berotralstat): Oral, Once-daily Treatment for Prevention of HAE Attacks:

  • BioCryst launched Orladeyo in the United States following U.S. Food and Drug Administration (FDA) approval on 3 December 2020, and product shipments began on 16 December 2020.
  • On 22 January 2021, the company announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan had granted marketing and manufacturing approval for oral, once-daily Orladeyo 150 mg for prophylactic treatment of HAE in adults and pediatric patients 12 years and older. Orladeyo is the first and only prophylactic HAE medication approved in Japan and will be commercialized in Japan by BioCryst’s partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization. Torii will launch Orladeyo in Japan following the successful completion of BioCryst’s pricing negotiations with the Japanese National Health Insurance System (NHI).
  • In Europe, the Committee for Medicinal Products for Human Use (CHMP) is scheduled to review the Orladeyo marketing authorization application this week. The company expects approval from the European Commission (EC) approximately 60 days following a positive opinion from the CHMP.
  • On 30 October 2020, the company announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) had 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 can gain access to Orladeyo for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the EC.
  • On 22 October 2020, the company announced that data from the first 24 weeks of the Phase 3 APeX-2 trial of Orladeyo in 121 HAE patients ages 12 years or older had been published online by the Journal of Allergy and Clinical Immunology.
  • On 13 November 2020, the company presented data in several abstracts at the 2020 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology across HAE patients, caregivers and treating physicians showing many patients experience a significant treatment burden associated with current prophylactic HAE therapies.
  • On 30 November 2020, the company announced that the journal Allergy had published data from the APeX-J trial, a randomized, placebo-controlled trial conducted in Japan evaluating ORLADEYO for the prophylactic treatment of HAE.

(Source: BioCryst)

2021-02-25T14:19:54+02:00February 25, 2021|HAEi News|