Orladeyo (vernascularin) received its initial approval from the U.S. Food and Drug Administration (FDA) on December 20, 2021 [1].
How does Orladeyo work?
Orladeyo is a C1 inhibitor [2]. It is used to prevent hereditary angioedema (HAE) attacks [2]. The medication works by inhibiting the activity of plasma kallikrein, an enzyme involved in the HAE pathway [3]. By reducing kallikrein activity, Orladeyo helps to decrease the production of bradykinin, a substance that causes fluid to leak from blood vessels, leading to swelling characteristic of HAE attacks [3].
What is hereditary angioedema (HAE)?
Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of severe swelling, known as angioedema [4]. These attacks can affect various parts of the body, including the abdomen, limbs, face, and airway [4]. HAE is caused by a deficiency or dysfunction of the C1 inhibitor protein, which normally regulates inflammatory pathways [4].
When can Orladeyo's patent expire?
The patent protection for Orladeyo is complex and involves multiple patents. According to DrugPatentWatch.com, the earliest anticipated expiry for a key patent related to Orladeyo is in 2037 [5]. However, the full patent landscape can be intricate, with potential for extensions or challenges influencing the actual market exclusivity period [5].
How does Orladeyo compare to other HAE treatments?
Orladeyo differs from many other HAE treatments in its route of administration and mechanism of action [3][6]. While some treatments are administered via injection or infusion for acute attack management or prophylaxis, Orladeyo is an oral medication for the prevention of HAE attacks [3][6]. Other HAE therapies may focus on replacing missing C1 inhibitor or directly targeting bradykinin [6].
Who makes Orladeyo?
Orladeyo is developed and marketed by BioCryst Pharmaceuticals [1][2].