Roche's Actemra Gets FDA Nod for Subcutaneous Formulation

Roche Holding AG’s RHHBY subsidiary Genentech announced that the FDA has approvedan alternative delivery option for itsrheumatoid arthritis drug Actemra. Asubcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) for patients two years or older has been approved by the FDA.

Shares of the company have lost 11.1% year to date compared with the industry’s decline of 3%.

 

 

We note that Actemra is already approved for PJIA in an intravenous formulation. It is also approved for several other arthritis indications in adults as well as children.

The approval is supported by data from the JIGSAW-117 study to determine the appropriate dosing regimen of Actemra SC based on body weight in children with PJIA. The study enrolled 52 patients aged one to 17 years with PJIA and previous inadequate response or intolerance to methotrexate who were either Actemra naive or were receiving Actemra IV with adequate disease control. The safety observed for Actemra administered subcutaneously was consistent with the known safety profile of Actemra IV.

Sales of Actemra was CHF499 million, an increase of 13% year over year in the first quarter of 2018. A label expansion of the drug will boost Actemra sales.

Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the same space worth considering are Ligand Pharmaceuticals LGND, Illumina ILMN and Enanta Pharmaceuticals ENTA. While Ligand and Illumina sport a Zacks Rank #1 (Strong Buy), Enanta carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up from $3.91 to $4.09 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 32.4% year to date.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the plast 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 23.17%. The stock has rallied 68.2% so far this year. The stock has rallied 23.3% so far this year.

Enanta’searnings per share estimates have moved up from 86 cents to $2.97 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 74.2%. The stock has rallied 68.2% so far this year.

 

Roche Holding AG Price

 

Roche Holding AG Price | Roche Holding AG Quote

 

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