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Roche (RHHBY) Gets FDA Nod for Influenza Drug Label Expansion

Zacks Equity Research
·4-min read

Roche RHHBY announced that the FDA has approved a supplemental New Drug Application (sNDA) for influenza drug, Xofluza. 

The drug is now approved as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis).

Per Roche, Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.

We note that the drug is already FDA-approved to treat acute uncomplicated influenza in people 12 years of age and older who have had influenza symptoms for not more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

A single-dose Xofluza was evaluated in the phase III BLOCKSTONE study for post-exposure prophylaxis.  The study evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members (12 years of age and older) who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group.

Meanwhile, Roche is also working with the FDA for a potential indication of Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to the disease.

Earlier in the month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Xofluza for the treatment of uncomplicated influenza in patients aged 12 years and above.  The committee also recommended the drug as a preventive treatment of influenza in individuals aged 12 years and above.

The stock has gained 1.4% in the year so far against the industry’s decline of 0.8%.

Label expansion of Roche’s existing drugs should boost its sales, as the company’s performance based on the metric in the first nine months of 2020 was pretty ho-hum due to the impact of the COVID-19 outbreak and competition from biosimilars.

Meanwhile, Roche entered into a partnership with Regeneron REGN for its new antiviral antibody cocktail to fight COVID-19. The antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the FDA. If the therapy proves to be safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the United States and Roche will develop, manufacture and distribute it outside the country.

Roche currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare space are Vanda Pharmaceuticals Inc. VNDA and Halozyme Therapeutics, Inc. HALO, both carrying a Zacks Rank #2 (Buy), presently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vanda’s earnings estimates have been raised 12 cents for 2020 in the past 30 days.

Halozyme’s earnings estimates have grown 15 cents for 2020 in the past 30 days.

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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
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