Netherlands approves BioCryst’s HAE drug ORLADEYO for reimbursement

Published 06/06/2025, 12:06
Netherlands approves BioCryst’s HAE drug ORLADEYO for reimbursement

RESEARCH TRIANGLE PARK, N.C. - BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that ORLADEYO® (berotralstat) has been approved for reimbursement in the Netherlands. This development follows a positive recommendation from the Zorginstituut Nederland, allowing patients aged 12 and older to use the drug for the routine prevention of hereditary angioedema (HAE) attacks. The company has shown remarkable growth, with revenue increasing by 41.67% over the last twelve months to $503.49 million, according to InvestingPro data.

The approval signifies the availability of ORLADEYO as a reimbursed medication across all major European countries, providing the HAE community with an oral, once-daily preventive therapy option. Abid Karim, general manager of Europe at BioCryst, expressed the company’s commitment to bringing ORLADEYO to as many HAE patients as possible and highlighted the significance of this milestone in making the treatment accessible. The company’s strong market position is reflected in its impressive 70.5% stock return over the past year, with InvestingPro analysts maintaining a bullish outlook and setting price targets up to $30.

ORLADEYO, which was granted marketing authorization by the European Commission in April 2021, is now commercially available in over 30 countries. The medication functions by reducing the activity of plasma kallikrein, which plays a role in the development of HAE attacks. The recommended dosage is one 150 mg capsule per day, with dosage adjustments suggested for patients with moderate or severe hepatic impairment.

BioCryst emphasizes that ORLADEYO is not intended for the treatment of acute HAE attacks and should not be used in such cases. The most common adverse reactions reported in patients receiving the drug include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

The company, known for leveraging structure-guided drug design to develop targeted therapeutics, continues to focus on improving the lives of individuals with rare diseases. BioCryst advises caution when using ORLADEYO with certain other medications due to potential interactions.

This news is based on a press release statement from BioCryst Pharmaceuticals, Inc. Investors and patients are advised to consider the full prescribing information and potential risks associated with ORLADEYO before making treatment decisions. For investors seeking deeper insights, InvestingPro offers comprehensive analysis of BioCryst’s financial health, including 12+ additional ProTips and detailed metrics that help evaluate the company’s growth potential and market position.

In other recent news, BioCryst Pharmaceuticals reported significant financial achievements, with Q1 2025 revenue reaching $145.5 million, surpassing the forecast of $127.9 million. This growth was largely attributed to the strong sales of their flagship product, Orladeyo, which generated $134 million, marking a 51% increase year-over-year. The company also improved its earnings per share to $0.00, outperforming the anticipated loss of $0.07. Following these results, Jefferies maintained a Buy rating on BioCryst, raising the stock’s price target from $12.00 to $14.00 due to the robust performance of Orladeyo.

Additionally, BioCryst presented new data at international conferences, demonstrating Orladeyo’s efficacy in reducing hereditary angioedema (HAE) attack rates across various age groups. The company highlighted that Orladeyo achieved a significant decrease in monthly attack rates for U.S. patients, with a reduction from 7.78-8.23 attacks at baseline to 1.24-1.90 after treatment. In terms of strategic initiatives, BioCryst extended its consulting agreement with former CFO Anthony Doyle to ensure continuity in financial operations during the transition period.

BioCryst also announced plans to advance its pipeline, with upcoming data releases related to Netherton syndrome and diabetic macular edema treatments expected later this year. The company emphasized its commitment to improving the lives of patients with rare diseases through innovative drug development. These developments reflect BioCryst’s strategic focus on expanding its market potential and maintaining financial stability.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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