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Roche (RHHBY) Actemra Gets Breakthrough Therapy Status

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Roche Holding AG (RHHBY - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its rheumatoid arthritis (RA) drug, Actemra (EU trade name: RoActemra), for the treatment of giant cell arteritis (GCA).

We note that the FDA usually grants Breakthrough Therapy status to speed up the development and review of drugs that are intended to treat serious diseases and provide access to patients as early as possible.

We remind investors that Roche had reported positive results from a phase III GiACTA study evaluating Actemra in patients with GCA earlier this June. Data demonstrated that Actemra, initially combined with a six month steroid (glucocorticoid) regimen, was more effective in sustaining remission through one year in comparison to a 6 or 12 month steroid-only regimen in patients with GCA. The company intends to present full data at a forthcoming medical meeting this year.


We are encouraged by the FDA granting Breakthrough Therapy status to Actemra for GCA. Per Roche’s press release, GCA, a form of vasculitis, is a chronic life-threatening autoimmune condition. There has been no approved treatment for the same in more than 50 years, representing a significant unmet need.

Note that Roche had received the first Breakthrough Therapy status for Actemra for the treatment of patients with systemic sclerosis (SSc) in Jun 2015. It is currently being evaluated in a phase III study for SSc.

Actemra is approved in both intravenous (IV) and subcutaneous (SC) formulations, for the treatment of adults with moderate-to-severe active RA. It can be used alone or with methotrexate in adults who are intolerant to, or have failed to respond to, other anti-rheumatic medications. IV formulation is approved in most major countries, for the treatment of polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis, in children aged two years and older.

Sales of Actemra grew 17% in the first half of 2016. Growth was driven by the uptake of the SC formulation, mainly in the U.S., Japan, France and the UK. Label expansion into additional indications will boost the sales of the drug further.

Zacks Rank & Key Picks

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Ophthotech Corporation (OPHT - Free Report) and Geron Corporation . All the three stocks sport a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika has seen its earnings estimates for 2016 rise 9.5% over the last 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped almost 23% year to date.

Ophthotech has posted an average positive surprise of 9.31% over the last four trailing quarters.

Geron has recorded an average positive surprise of 20.78% over the trailing four quarters.

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