Roche (RHHBY) Gets FDA Nod for Shorter Infusion Time of Ocrevus
Roche AG RHHBY announced that the FDA approved a shorter two-hour infusion time for Ocrevus, dosed twice-yearly tothose living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomized, double-blind ENSEMBLE PLUS study.
Shares of the company have gained 6.9% compared with the industry’s growth of 4.8%.
We note that Ocrevus is already approved in the United States for treating primary progressive MS. It is the first and only drug approved for treating relapsing MS, including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS. The drug is approved for twice-a-year intravenous administration.
The latest decision is based on data from the ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRs for a two-hour Ocrevus infusion time versus the previously-approved 3.5-hour time in patients with RRMS. Roche noted that the first dose was administered per the approved dosing schedule (two 300 mg intravenous [IV] infusions separated by two weeks), while the second or later doses (600 mg IV infusion) were given over a shorter, two-hour time.
The European Medicines Agency (EMA) approved the two-hour infusion time in May 2020 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
The sales of Ocrevus have been encouraging and increased 29% in the first nine months of 2020.In the United States, growth was driven both by new and returning patients, with a higher proportion of sales coming from returning patients.
Roche Holding AG Price
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Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. ARPO, Aptose Biosciences Inc. APTO and Alimera Sciences Inc. ALIM, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.
Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.
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