Roche's (RHHBY) SBLA For Asthma Drug Xolair Accepted By FDA
Zacks Investment Research | Dec 10, 2019 08:54PM ET
Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) subsidiary, Genentech, announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for its allergic asthma drug, Xolair (omalizumab). The sBLA is filed for the treatment of nasal polyps in adult patients aged 18 years or above with inadequate response to intranasal corticosteroids. The FDA is expected to make a decision on the approval of the same by the third quarter of 2020. If approved, Xolair will become the first antibody to help reduce the size of nasal polyps and improve symptoms by targeting and blocking immunoglobulin E (IgE).
We note that Xolair is already approved for the treatment of moderate-to-severe, or severe, persistent allergic asthma in people aged six years or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people aged 12 years or older who continue to have hives that are not controlled by H1 antihistamines.
This sBLA is supported by results from the phase III POLYP 1 and POLYP 2 studies, which showed that Xolair met both co-primary and multiple secondary endpoints. The drug significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) in both studies.
The results showed that Xolair, an injectable biologic medicine designed to target and block IgE, was well tolerated, while safety profile was consistent with that observed in previous studies in patients with moderate-to-severe allergic asthma and CIU.
The company’s shares have rallied 23.5% in the year so far compared with the Original post
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