Roche Holding AG RHHBY 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, 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 asthma drug, Nucala, for treating pediatric patients. Earlier this year, AstraZeneca, plc AZN 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.

Today’s Stocks from Zacks’ Hottest Strategies

It’s hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 – 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we’re willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
AstraZeneca PLC (AZN): Free Stock Analysis Report
 
Novartis AG (NVS): Free Stock Analysis Report
 
GlaxoSmithKline plc (GSK): Free Stock Analysis Report
 
Roche Holding AG (RHHBY): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research