Orladeyo (berotralstat) by BioCryst Pharmaceuticals Earns FDA Approval
A new cardiovascular agent treats Hereditary Angioedema (HAE)
The U.S. Food and Drug Administration (FDA) has issued BioCryst Pharmaceuticals approval for its new drug, Orladeyo (berotralstat), with an indication to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Orladeyo, a plasma kallikrein inhibitor, is available by prescription only and is produced in orally-administered 150mg capsules that are taken once daily. It works by decreasing the activity of plasma kallikrein in patients diagnosed with HAE.
Orladeyo’s oral formulation is a competitive advantage
BioCryst Pharmaceuticals may have an important brand and market access strategy over its rivals with Orladeyo as it can be taken orally. The HAE therapies of two competitors are administered by injection which could be considered by patients and prescribing physicians as less convenient:
- Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) is made by CSL Behring GmbH (ASX: CSL) and was approved by the FDA in 2017
- Takhzyro (lanadelumab-flyo) is a monoclonal antibody (mAb) marketed by Takeda (NYSE: TAK) that was issued FDA approval in 2018
The company’s market access strategy will need to establish Orladeyo’s clinical and cost-effectiveness against these two products with managed care organizations (MCOs), pharmacy benefits managers (PBMs) and specialty pharmacies as well as introduce it to the broad cardiology and internal medicine physician community nationwide.
BioCryst is a compact, R&D-focused biopharmaceutical enterprise
Founded in 1986, BioCryst (NASDAQ: BSX) is headquartered in Durham, North Carolina and operates an advanced research & development facility known as its Discovery Center of Excellence in Birmingham, Alabama. It is a commercial-stage biotech company that focuses on rare diseases.
BioCryst’s other well-known product is Rapivab (peramivir injection) that is FDA approved and indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.
The FDA has been on a roll with evaluating advanced new therapies for rare diseases and improving their availability to patients and medical professionals
The FDA has been heavily burdened with the challenges of COVID-19 but it has not abandoned the patients or clinicians seeking new drug treatments for oncology and rare diseases. Over the last several months, these are just some of the complex products that have passed the clinical scrutiny of the FDA and are now approved:
- Eiger Pharmaceuticals’ Zokinvy (lonafarnib) Earns FDA Approval
- Rhythm Pharmaceuticals’ Imcivree (setmelanotide) Earns FDA Approval
- Y-mAbs Therapeutics Earns FDA Approval For Danyelza (naxitamab-gqgk)
- Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Earns FDA Ebola Approval
- New Genentech Oncology Drug Gavreto Approved by FDA
- Astex Pharmaceuticals’ New Oncology Therapy Inqovi (decitabine and cedazuridine) Earns FDA Approval
- Jazz Pharmaceuticals/PharMar Lung Cancer Therapy Zepzelca (lurbinectedin) Earns FDA Approval
- Genentech Breast Cancer Therapy Phesgo Earns FDA Approval
In the scheme of things, the FDA is clearly demonstrating its ability to perform at a high level as the pandemic subsists.
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