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Roche’s Child Arthritis Drug’s New Formulation Gets FDA Nod

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Roche Holding AG’s RHHBY subsidiary, Genentech announced that the FDA has approved a label expansion for its arthritis drug, Actemra. The FDA approved a subcutaneous (SC) formulation — a prefilled syringe that can be injected at home —of Actemra for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years or older.

Shares of the company have lost 2.0% year to date compared with the industry’s growth of 6.6%.

We note that Actemra is already approved for SJIA in an intravenous formulation. It is also approved for several other arthritis indications in adults as well as children. SJIA is the rarest form of juvenile idiopathic arthritis (JIA) with limited treatment options. With the latest approval, juvenile patients have the flexibility to take Actemra at home.


The approval is supported by data from the JIGSAW-117 study, conducted to determine the appropriate dosing regimen of Actemra SC. The study enrolled 51 patients aged one to 17 years with SJIA and previous inadequate response or intolerance to NSAIDs, and corticosteroids who were either Actemra naive or were receiving Actemra IV with adequate disease control. The safety observed for Actemra SC was consistent with the known safety profile of Actemra IV, with the exception of injection site reactions (ISRs).

Sales of Actemra increased 13% year over year in the first half of 2018. A label expansion of the drug should boost sales, further.

Actemra is also marketed for another form of JIA, which is polyarticular juvenile idiopathic arthritis (PJIA). Other drugs marketed for this indication are Abbvie Inc.’s ABBV Humira and Bristol-Myers Squibb Company’s BMY Orencia.

Zacks Rank & Other Stock to Consider

Roche is a Zacks Rank #2 (Buy) stock.

Another similar-ranked stock in the same space is Eli Lilly and Company LLY. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.53 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 22.7% in the past three months.

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