AstraZeneca has previously submitted a supplemental Biologics License Application (sBLA) for their chronic rhinosinusitis with nasal polyps (CRwNP) treatment, and now, the FDA has responded. In a complete response letter (CRL), the regulatory agency has requested more data on this therapy, which is called Fasenra (also known by the generic name, benralizumab).

Details of the CRL

Within their letter, the FDA asked for more data than what was included in the initial application. The agency wanted to see more than the information supplied from the OSTRO Phase III study, which met primary endpoints while maintaining the drug’s safety profile.

In response to the FDA’s letter, AstraZeneca plans to work very closely with the regulatory agency. The hope is that the ongoing, Phase III ORCHID trial can fill the gaps left in the data from the company’s first Phase III trial.

You can read more about the CRL here.

About Chronic Rhinosinusitis

According to the Mayo Clinic, chronic rhinosinusitis is a disorder that occurs when inflammation in the sinuses persists for more than three months despite treatment. It causes symptoms such as nasal inflammation, stuffy nose, difficulty breathing, postnasal drainage, congestions, reduced senses of taste and smell, and pain, swelling, and tenderness in the face. Symptoms that are not as common but may still appear include headache, sore throat, bad breath, ear pain, cough, the need to clear one’s throat often, aches in the teeth and upper jaw, and fatigue.

There are many possible cases of this condition, but Fasenra is being evaluated specifically for chronic rhinosinusitis caused by nasal polyps. These growths form in the nasal passages and sinuses, consequently blocking them. In terms of existing treatment options, doctors may recommend nasal corticosteroids, oral/injected corticosteroids, saline nasal irrigation, and aspirin desensitization treatment. Additionally, dupilumab and omalizumab are approved to treat CRwNP.