Roche's (RHHBY) SBLA For Asthma Drug Xolair Accepted By FDA

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 industry's growth of 8.0%.

The label expansion of the drug for this indication should boost sales, given the demand. Nasal polyps is a common and potentially debilitating condition in adults, impacting 13 million people in the United States.

Roche is making efforts to expand its portfolio beyond oncology into immunology. Apart from Xolair, the company’s immunology portfolio includes Actemra for rheumatoid arthritis, Rituxan for rheumatoid arthritis granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris (PV), Pulmozyme for cystic fibrosis, and Esbriet for idiopathic pulmonary fibrosis (IPF).

Roche has a collaboration agreement with Novartis (NYSE:NVS) for Xolair.

Zacks Rank & Other Stocks to Consider

Roche currently carries a Zacks Rank #2 (Buy).

A few similar-ranked stocks in the biotech sector are GlaxoSmithKline plc. (NYSE:GSK) and Merck & Co. Inc. (NYSE:MRK) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings per share estimates have increased from $2.98 to $3.17 for 2019 and from $3.01 to $3.10 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.

Merck’s earnings per share estimates have increased from $4.91 to $5.15 for 2019 and from $5.37 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.

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