Roche's Xolair sBLA for Self Administration Accepted by FDA
Roche Holding AG’s RHHBY subsidiary, Genentech, announced that the FDA accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (omalizumab) across all approved U.S. indications.
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.
The Xolair prefilled syringe, if approved, would be available for self-administration by select patients or administration by their caregivers. The decision on approval is expected by the first quarter of 2021. Once the Xolair therapy is established, the correct subcutaneous injection technique and recognition of the early signs and symptoms of anaphylaxis will be explained to the patient or the caregiver by a healthcare professional.
Roche has a collaboration agreement with Novartis NVS for Xolair.
The shares of the company have gained 6.7% year to date compared with the industry’s growth of 1.7%.
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).
Immuno-oncology is a key area of focus for Roche, with multiple candidates currently under development. Tecentriq is the company’s leading immuno-oncology drug for multiple indications. Tecentriq is approved in the European Union and the United States for previously-treated metastatic NSCLC and certain types of untreated or previously-treated metastatic urothelial carcinoma (mUC).
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Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $3.45 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.
Horizon Therapeutics’ earnings estimates have increased from $1.77 to $2.90 for 2020 and from $2.72 to $4.34 for 2021 over the past 60 days.
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