According to a story from finanznachrichten.de, the UK drug development company AstraZeneca recently announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for the company’s medical product benralizumab (marketed as Fasenra). The designation is as a treatment for eosinophilic granulomatosis with polyangiitis (EGPA). Fasenra is currently approved as a supplemental treatment for eosinophilic asthma.
About Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Eosinophilic granulomatosis with polyangiitis (EGPA), which is also known as Churg-Strauss syndrome, is a very rare autoimmune illness which is characterized by inflammation of small and medium blood vessels in people with a history of allergic airway hypersensitivity. The exact cause of EGPA unknown but the only prominent risk factor is prior allergic airway conditions such as asthma. The disease begins with allergic reactions such as allergic rhinitis, sinusitis, and asthma. Later symptoms include cough, weight loss, fever, gastrointestinal bleeding, vasculitis (blood vessel inflammation), blood clots, cell death, abdominal pain, asthma, heart disease, and night sweats. These symptoms may develop slowly over months or years and may relapse and remit. Treatment involves immune system suppressants such as steroids, methotrexate, and mepolizumab, the last of which is first FDA approved therapy for EGPA. To learn more about EGPA, click here.
About Orphan Drug Designation
Orphan Drug designation is typically reserved for therapies that are intended to treat diseases that are considered rare, which is defined as any disease that affects less than 200,000 people in the US. To qualify for this designation, a medication must display potential advantages in effectiveness or safety over currently available therapies or address a currently unmet medical need. Orphan Drug designation confers several benefits to the recipient company, such as the waiving of certain fees, tax breaks, and a seven year period of market exclusivity if the drug is approved by the FDA.
Fasenra is known for its ability to quickly and effectively deplete eosinophils in the blood, which play a key role in EGPA and eosinophilic asthma. Fasenra has the potential to play a vital role in a large number of eosinophil driven diseases and conditions.
