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Roche Gets FDA Approval for New Formulation of Asthma Drug

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Roche Holding AG (RHHBY - Free Report) announced that the FDA has approved expansion prefilled syringe formulation of its asthma drug, Xolair(omalizumab). Xolair is approved for use in a 75 mg/0.5 mL and 150 mg/1 mL single-dose PFS formulation for both the approved indications of the drug - allergic asthma and chronic idiopathic urticaria (chronic hives without a known cause). Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.

We note that Xolair is co-developed by Genentech and Novartis Pharmaceuticals Corp., subsidiaries of Roche and Novartis (NVS - Free Report) , respectively. It is the the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications.

The new formulation, known as Xolair PFS, will be available in the United States by the end of 2018. The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.

Approval of the new Xolair formulation follows the FDA’s granting of Breakthrough Therapy designation to the drug in August 2018 for several food allergies. The designation was granted for the prevention of severe allergic reactions, following accidental exposure to one or more food items in people with allergies, based on data from seven clinical studies evaluating the drug. The studies evaluated Xolair as monotherapy or in combination with oral immunotherapy.

Separately, Tusk Therapeutics Ltd, a developer of immuno-oncology drugs announced that it has been acquired by Roche. Per the deal, Roche will pay an upfront cash payment of €70 million, plus additional contingent payments of up to €585 million based on achievements of certain predetermined milestones.

Shares of Roche have decreased 4.5% so far this year compared with the industry's growth of 7.0%.

In other developments in the asthma space, the European Commission (“EC”) gave a marketing approval to GlaxoSmithKline Plc.’s (GSK - Free Report) asthma drug, Nucala, for treating pediatric patients. Earlier this year, AstraZeneca, plc (AZN - Free Report) was granted approval by the EC for its asthma disease drug, Fasenra (benralizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adult patients. AstraZeneca received approval from the FDA for this indication in November, last year.

Zacks Rank

Roche carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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