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BOGOTA - Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has approved BioCryst Pharmaceuticals’ (NASDAQ:BCRX) oral medication ORLADEYO (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in patients 12 years and older, the company announced Friday. The approval comes as BioCryst shows strong business momentum, with revenue growing 41.67% over the last twelve months and analysts on InvestingPro maintaining a bullish outlook for the company.
The approval represents the sixth regulatory authorization for ORLADEYO in Latin America, following previous approvals in Chile, Argentina, Brazil, Mexico and Peru.
ORLADEYO is the first and only oral therapy specifically designed for HAE attack prevention, requiring just one capsule daily. The medication works by decreasing plasma kallikrein activity, a key factor in HAE attacks.
"Following this positive decision from INVIMA, we are working with the team at Pint Pharma to bring our oral, once-daily prophylactic therapy to patients in Colombia," said Charlie Gayer, chief commercial officer of BioCryst.
BioCryst has an exclusive collaboration with Pint Pharma GmbH to register and promote the medication throughout Latin America. Under their agreement, Pint handles marketing authorizations and commercialization in the region.
The most common adverse reactions reported in patients receiving ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. The medication is not approved for treating acute HAE attacks.
Hereditary angioedema is a rare genetic disorder characterized by recurring episodes of severe swelling in various body parts, which can be painful, disfiguring, and potentially life-threatening when affecting the airway.
This article is based on a press release statement from BioCryst Pharmaceuticals.
In other recent news, BioCryst Pharmaceuticals announced that ORLADEYO® (berotralstat) has been approved for reimbursement in the Netherlands, marking its availability as a reimbursed medication across major European countries. The company also reported a significant increase in ORLADEYO sales, reaching $134 million, a 51% rise from the previous year, and adjusted its financial year 2025 revenue guidance to $580-600 million. Additionally, Jefferies maintained a Buy rating on BioCryst, raising the stock’s price target from $12.00 to $14.00, citing the strong performance of ORLADEYO as a key factor. Recent data presented at international conferences demonstrated the drug’s efficacy in reducing hereditary angioedema (HAE) attack rates across various age groups. Furthermore, BioCryst extended its consulting agreement with former CFO Anthony Doyle to ensure continuity during the transition of the financial officer role. The company’s ongoing studies and real-world evidence continue to support the effectiveness of ORLADEYO in managing HAE symptoms. BioCryst remains committed to advancing its pipeline, with upcoming data expected for its Netherton syndrome and diabetic macular edema treatments. These developments underscore BioCryst’s dedication to improving the lives of individuals with rare diseases.
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