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Roche (RHHBY) Actemra Gets CHMP Recommendation for COVID-19
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Roche (RHHBY - Free Report) recently announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended extending the marketing authorization for rheumatoid arthritis drug Actemra/RoActemra (tocilizumab).
Actemra has been recommended for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
The recommendation comes amid rising cases in Europe. The CHMP began an accelerated assessment of Actemra/RoActemra in August 2021.
WHO has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still effectively manage patients with severe COVID-19 following the recent emergence of the new variant of concern, Omicron.
The recommendation was based on results from phase III studies — COVACTA, EMPACTA and REMDACTA — and the University of Oxford’s Randomised Evaluation of COVID-19 Therapy (RECOVERY) study, which was supported by Roche.
A final decision from the European Commission (“EC”) on the same is expected shortly.
In June 2021, Actemra/RoActemra received an Emergency Use Authorization (EUA) from the FDA for the intravenous treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Shares of Roche have gained 13.4% so far this year compared with the industry’s growth of 12.3%.
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Apart from launching quite a few diagnostics tests to detect the virus, Roche entered into a partnership with Regeneron (REGN - Free Report) to jointly develop antibody cocktail Ronapreve (casirivimab and imdevimab), known as REGEN-COV in the United States.
Last month, the EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and are at increased risk of progressing to severe COVID-19, and to prevent the disease.
Regeneron and Roche intend to submit a future Type II Variation to the EMA that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.
While Regeneron invented the antibody cocktail, Roche is primarily responsible for development and distribution outside the United States.
As the pandemic continues to wreak havoc with new variants, pharma/biotech companies are striving hard to develop new ammunition for combating the same.
The FDA recently expanded EUA for Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from newborns to 12 years olds.
With the expanded EUA, Lilly’s bamlanivimab and etesevimab can now be given both for the treatment of patients with COVID-19 as well as for post-exposure prophylaxis in high-risk pediatric and infant patients (less than 12 years of age).
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $3.02 to $3.06 in the past 30 days. The same for 2022 has increased from $3.23 to $3.26 in the past 30 days. Shares of Glaxo have risen 13.4% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.
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Roche (RHHBY) Actemra Gets CHMP Recommendation for COVID-19
Roche (RHHBY - Free Report) recently announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended extending the marketing authorization for rheumatoid arthritis drug Actemra/RoActemra (tocilizumab).
Actemra has been recommended for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
The recommendation comes amid rising cases in Europe. The CHMP began an accelerated assessment of Actemra/RoActemra in August 2021.
WHO has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still effectively manage patients with severe COVID-19 following the recent emergence of the new variant of concern, Omicron.
The recommendation was based on results from phase III studies — COVACTA, EMPACTA and REMDACTA — and the University of Oxford’s Randomised Evaluation of COVID-19 Therapy (RECOVERY) study, which was supported by Roche.
A final decision from the European Commission (“EC”) on the same is expected shortly.
In June 2021, Actemra/RoActemra received an Emergency Use Authorization (EUA) from the FDA for the intravenous treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Shares of Roche have gained 13.4% so far this year compared with the industry’s growth of 12.3%.
Apart from launching quite a few diagnostics tests to detect the virus, Roche entered into a partnership with Regeneron (REGN - Free Report) to jointly develop antibody cocktail Ronapreve (casirivimab and imdevimab), known as REGEN-COV in the United States.
Last month, the EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and are at increased risk of progressing to severe COVID-19, and to prevent the disease.
Regeneron and Roche intend to submit a future Type II Variation to the EMA that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.
While Regeneron invented the antibody cocktail, Roche is primarily responsible for development and distribution outside the United States.
As the pandemic continues to wreak havoc with new variants, pharma/biotech companies are striving hard to develop new ammunition for combating the same.
The FDA recently expanded EUA for Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from newborns to 12 years olds.
With the expanded EUA, Lilly’s bamlanivimab and etesevimab can now be given both for the treatment of patients with COVID-19 as well as for post-exposure prophylaxis in high-risk pediatric and infant patients (less than 12 years of age).
Roche currently carries a Zacks Rank #2 (Buy). Another top-ranked large-cap pharma stock is GlaxoSmithKline (GSK - Free Report) , which currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $3.02 to $3.06 in the past 30 days. The same for 2022 has increased from $3.23 to $3.26 in the past 30 days. Shares of Glaxo have risen 13.4% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.