Roche (RHHBY) Gets EU Approval for Xofluza in New Patient Base
Roche Holding AG RHHBY announced that the European Commission (“EC”) approved its influenza drug Xofluza (baloxavir marboxil) for addressing a new patient population.
The EC has now approved Xofluza for the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in children aged one year and above.
Following the latest nod by the EC, Xofluza is now approved for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, as well as in adolescents and adults in the EU.
Xofluza has now become the first single-dose, oral influenza medicine to be approved in Europe.
Shares of Roche have plunged 21.2% in the past year compared with the industry’s decline of 14.2%.
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The latest nod from the EU was based on data from the phase III miniSTONE-2 and BLOCKSTONE studies.
Per the company, the miniSTONE-2 study met its primary end-point of safety and showed that treatment with Xofluza reduced the length of time that influenza was released from the body by more than two days versus Tamiflu (oseltamivir).
Data from the BLOCKSTONE study showed that treatment with Xofluza led to a statistically significant prophylactic effect after a single oral dose, reducing the risk of people developing influenza following contact with someone with the disease by 86% compared with placebo.
We note that Xofluza was approved for treating uncomplicated influenza, and post-exposure prophylaxis of influenza in adults and adolescents aged 12 years and above in 2021. The medicine is now approved for the treatment of influenza types A and B in more than 70 countries across the world.
In the United States, Xofluza is approved for the treatment of influenza in people aged 12 years and older who have had influenza symptoms for no more than 48 hours and are otherwise healthy or at high risk of developing influenza-related complications. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with the disease.
Last August, the FDA approved a supplemental new drug application for Xofluza to treat acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
Additionally, Xofluza was approved by the FDA for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years following contact with someone with the disease.
Xofluza is being further evaluated in a phase III development program, including children under the age of one (NCT03653364), as well as to assess the potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212).
Zacks Rank & Other Stocks to Consider
Roche currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. SNDX, Celularity Inc. CELU and Arcus Biosciences, Inc. RCUS, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 6.5% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Celularity have narrowed 17.3% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01%, on average.
Loss per share estimates for Arcus Biosciences have narrowed 5.9% for 2023 in the past 60 days.
Earnings of Arcus Biosciences surpassed estimates in two of the trailing four quarters, met the same once and missed on the other occasion. RCUS witnessed an earnings surprise of 56.74% on average.
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