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Roche's Ocrevus Line Extension Application Moves Forward
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Roche (RHHBY - Free Report) announced that the FDA has accepted a supplemental Biologics License Application (sBLA), seeking approval for a shorter infusion time for its multiple sclerosis (“MS”) drug, Ocrevus. The sBLA, if approved, will reduce infusion time from the current three-and-a-half hours to two hours. A similar regulatory application has also been validated by the European Medicines Agency.
Please note that Ocrevus is already approved for treating primary progressive MS. It is the first and only drug approved for treating relapsing MS, including relapsing-remitting MS and active, or relapsing, secondary progressive MS. The drug is approved as twice-a-year intravenous administration.
Regulatory applications were filed based on data from ENSEMBLE PLUS study, which evaluated a two-hour Ocrevus Infusion time compared to three-and-a-half hour infusion time in relapsing-remitting MS patients for a proportion of patients with infusion-related reactions (IRRs). Data from the study showed that both regimens had comparable frequency and severity of IRRs. Detailed data will be presented to regulatory authorities as soon as possible.
The company expects a decision from the regulatory authorities in the United States and Europe by the end of this year.
Ocrevus has shown strong growth trend in the past couple of quarters. Sales of the drug grew 57% year over year in the fourth quarter of 2019. The shorter infusion time may boost the drug’s sales further. We note that, the drug faces stiff competition from MS drugs of Biogen (BIIB - Free Report) , the leader in the U.S. market.
Shares of Roche have gained 6.3% so far this year against the industry’s decrease of 1.3%.
In a separate press release, the company announced that the FDA has approved the cobas HPV test for use on the company’s proprietary fully automated, high-throughput cobas 6800/8800 systems. The cobas HPV test was previously approved for use on the company’s cobas 4800 System. The recent approval will help molecular laboratories to achieve the efficiency and scale to meet the demand for high-volume cervical screening programs.
The company’s cobas 6800/8800 systems are also being used for cobas SARS-CoV-2 test for qualitative detection of coronavirus by analyzing nasopharyngeal and oropharyngeal swab samples. It has also developed a new serology test, Elecsys, for detecting antibodies in people who have been exposed to SARS-CoV-2
Meanwhile, Roche’s rheumatoid arthritis (“RA”) drug Actemra is currently being investigated for the treatment of patients hospitalized with severe infection due to COVID-19.
Given the severity of the disease, several companies are testing their marketed drugs in studies to check the inflammatory response in patients with the deadly coronavirus infection, which includes Incyte (INCY - Free Report) and Regeneon (REGN - Free Report) .
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Roche's Ocrevus Line Extension Application Moves Forward
Roche (RHHBY - Free Report) announced that the FDA has accepted a supplemental Biologics License Application (sBLA), seeking approval for a shorter infusion time for its multiple sclerosis (“MS”) drug, Ocrevus. The sBLA, if approved, will reduce infusion time from the current three-and-a-half hours to two hours. A similar regulatory application has also been validated by the European Medicines Agency.
Please note that Ocrevus is already approved for treating primary progressive MS. It is the first and only drug approved for treating relapsing MS, including relapsing-remitting MS and active, or relapsing, secondary progressive MS. The drug is approved as twice-a-year intravenous administration.
Regulatory applications were filed based on data from ENSEMBLE PLUS study, which evaluated a two-hour Ocrevus Infusion time compared to three-and-a-half hour infusion time in relapsing-remitting MS patients for a proportion of patients with infusion-related reactions (IRRs). Data from the study showed that both regimens had comparable frequency and severity of IRRs. Detailed data will be presented to regulatory authorities as soon as possible.
The company expects a decision from the regulatory authorities in the United States and Europe by the end of this year.
Ocrevus has shown strong growth trend in the past couple of quarters. Sales of the drug grew 57% year over year in the fourth quarter of 2019. The shorter infusion time may boost the drug’s sales further. We note that, the drug faces stiff competition from MS drugs of Biogen (BIIB - Free Report) , the leader in the U.S. market.
Shares of Roche have gained 6.3% so far this year against the industry’s decrease of 1.3%.
In a separate press release, the company announced that the FDA has approved the cobas HPV test for use on the company’s proprietary fully automated, high-throughput cobas 6800/8800 systems. The cobas HPV test was previously approved for use on the company’s cobas 4800 System. The recent approval will help molecular laboratories to achieve the efficiency and scale to meet the demand for high-volume cervical screening programs.
The company’s cobas 6800/8800 systems are also being used for cobas SARS-CoV-2 test for qualitative detection of coronavirus by analyzing nasopharyngeal and oropharyngeal swab samples. It has also developed a new serology test, Elecsys, for detecting antibodies in people who have been exposed to SARS-CoV-2
Meanwhile, Roche’s rheumatoid arthritis (“RA”) drug Actemra is currently being investigated for the treatment of patients hospitalized with severe infection due to COVID-19.
Given the severity of the disease, several companies are testing their marketed drugs in studies to check the inflammatory response in patients with the deadly coronavirus infection, which includes Incyte (INCY - Free Report) and Regeneon (REGN - Free Report) .
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Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
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