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Intercept's (ICPT) Ocaliva Gets Favorable FDA Panel Vote

Intercept Pharmaceuticals, Inc. ICPT announced that the FDA’s Gastrointestinal Drugs Advisory Committee has voted unanimously (in the ratio of 17 to 0) in favor of the company’s lead pipeline candidate, Ocaliva (obeticholic acid).

The committee recommended accelerated approval of Ocaliva for the treatment of patients suffering from primary biliary cholangitis (PBC) (previously known as primary biliary cirrhosis).

We remind investors that the FDA had extended the Prescription Drug User Fee Act (PDUFA) date for priority review of Ocaliva by three months in Dec 2015. The agency was previously supposed to give a decision by Feb 29, 2016. However, it requested additional clinical data analyses, which Intercept has submitted. Consequently, the FDA now requires additional time for a full review of the submission and has extended the PDUFA date by three months to May 29, 2016.

Although the FDA is not bound to abide by the Advisory Committee's recommendation, it generally takes the same into consideration while reviewing candidates. Upon approval, Ocaliva would be the first new treatment for PBC in almost two decades. We note that ursodeoxycholic acid (UDCA) is the only drug currently approved in the U.S. for the treatment of PBC. However, a substantial number of patients treated with UDCA have a suboptimal response or are intolerant to treatment, which has left them at a significantly high risk of an adverse outcome.

A potential approval of Ocaliva in May 2016 should boost the growth potential of the company substantially.

Intercept Pharma currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, ArQule Inc. ARQL and Sucampo Pharmaceuticals SCMP. All the three stocks sport a Zacks Rank#1 (Strong Buy).

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ACTELION LTD (ALIOF): Free Stock Analysis Report
 
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