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Roche (RHHBY) Arthritis Drug Actemra sBLA Accepted by FDA

Roche Holding AGRHHBY announced that the FDA has accepted the company's Supplemental Biologics License Application (sBLA) for arthritis drug Actemra for the treatment of giant cell arteritis (GCA).

The FDA also granted Priority Review Designation for Actemra for the treatment of GCA based on positive results from the phase III study, GiACTA.

Shares of Roche have underperformed the Zacks classified Large Cap Pharmaceuticals industry in the last one year. In fact, the stock lost 11.1% during this time frame, compared with a decline of 3.1% for the industry.

The study evaluated Actemra in GCA patients. Results from the study showed Actemra when initially combined with a six-month steroid (glucocorticoid) regimen was more effective in sustaining remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.

We remind investors that priority review designation is generally granted to drugs that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. Earlier, in Oct 2016, Roche obtained Breakthrough Therapy Designation in the U.S. for Actemra for the treatment of GCA.

As per estimates, GCA impacts over 200 per 100,000 persons in the U.S. over the age of 50, and the disease is two to three times more likely to affect women than men thereby underscoring the need for treatments for the same. Mostly steroids (corticosteroids) are subscribed for GCA.

We note that Actemra is approved for the treatment of adult patients suffering from moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX) that did not provide enough relief. Actemra is also approved to be used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older.

A label expansion of the drug will boost Actemra sales.

Roche currently carries a Zacks Rank #5 (Strong Sell). Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Approval of new drugs and therapies is critical for Roche at this juncture as the company has been facing stiff generic competition for some of its drugs like Pegasys, Xeloda and Valcyte.

In addition, possibility of stiff competition from biosimilars looms large on some of Roche's key drugs such as Avastin, Rituxan and Herceptin over the long term. The biosimilar versions of MabThera and Herceptin are expected to enter the market soon.

Roche Holding AG Price and Consensus

Roche Holding AG Price and Consensus | Roche Holding AG Quote

Key Picks in the Sector

Some better-ranked stocks in the health care sector include Enzo Biochem, Inc. ENZ , Sunesis Pharmaceuticals, Inc. SNSS and Sucampo Pharmaceuticals SCMP . While Sucampo sports a Zacks Rank #1 (Strong Buy), both Sunesis and Enzo Biochem carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sucmapo's earnings estimates were stable at $1.22 for 2016 but have increased from $1.58 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.

Enzo Biochem's loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 44.5% in the past one year.

Sunesis' loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

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Roche Holding AG (RHHBY): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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