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Roche's (RHHBY) Xolair Gets FDA Nod for Label Expansion

Roche RHHBY announced that the FDA has approved the label expansion of asthma drug, Xolair.

The agency approved the company’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Per the company, Xolair is the first biologic approved for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation.

We note that Xolair is already approved for the treatment of moderate-to-severe persistent allergic asthma in people 6 years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids. The drug is also approved for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

Label expansion of the drug into additional indications will increase the sales potential of the same. Roche has a collaboration agreement with Novartis NVS to develop and co-promote Xolair in the United States.

Separately, the FDA approved Gavreto (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The approval came under the FDA’s accelerated approval program based on data from the phase I/II ARROW study.

Blueprint Medicines BPMC and Roche are co-developing Gavreto for the treatment of patients with various types of RET-altered cancers.

Earlier, in September, the FDA granted accelerated approval to Gavreto for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Separately, Roche announced that its serology (blood) test, Elecsys Anti-SARS-CoV-2 S antibody test, has received Emergency Use Authorization (EUA) from the FDA. The test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus.

The stock has gained 2.7% in the year so far compared with the industry’s growth of 1.4%.

Label expansion of Roche’s existing drugs should boost its sales, as the pharmaceutical division sales in the first nine months of 2020 were pretty ho-hum due to the impact of the COVID-19 outbreak and competition from biosimilars.

Roche currently carries a Zacks Rank #3 (Hold).  A better-ranked stock in the healthcare sector is Halozyme Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates have grown 18 cents for 2020 in the past 30 days.

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