Intercept Pharmaceuticals Inc (ICPT) Comments on Ocaliva Safety and Dosing

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) provided comment on the Ocaliva (obeticholic acid or OCA) Dear Healthcare Provider (DHCP) letter issued on September 12, 2017, and the subsequent drug safety communication issued by the U.S. Food and Drug Administration (FDA) on September 21, 2017.

Ocaliva was approved in the U.S. in May 2016 (and subsequently in the European Union and Canada) for the treatment of patients with primary biliary cholangitis (PBC) with an inadequate response to, or intolerant of the standard of care, UDCA. PBC is a rare and life-threatening progressive liver disease that primarily afflicts women and is a leading cause of liver failure with resulting need for liver transplant in women. Ocaliva therefore represents an important treatment option for patients with PBC and since its approval more than 3,000 patients have been treated with Ocaliva in the U.S. alone. More than 150 patients are enrolled in ongoing open label phases of Intercept’s Phase 2 and Phase 3 clinical trials and have been on OCA treatment for periods ranging from approximately three to seven years.

Label Recommended Ocaliva Dosing

Recommended dosing in the label for Ocaliva in earlier stage PBC patients with no or mild hepatic impairment (non-cirrhotic or Child-Pugh A cirrhosis) starts at 5 mg once daily, increasing after three months to 10 mg once daily based on tolerability and treatment response. However, in late stage patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), recommended dosing starts at 5 mg once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. The reason for this less frequent dosing is that systemic and hepatic concentrations of Ocaliva are predicted to significantly increase in such patients and dose-related liver adverse reactions have previously been documented in PBC patients participating in clinical trials.

Recently Issued Dear Healthcare Provider Letter and FDA Safety Communication

In the course of Intercept’s post-marketing pharmacovigilance activities, deaths have been reported in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis). In an analysis performed by Intercept and in consultation with the FDA, Intercept concluded that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than the recommended weekly dose in such patients. As a result, Intercept issued the DHCP letter and the FDA subsequently issued their own safety communication to reinforce recommended label dosing. Both communications remind healthcare providers of the importance of the recommended reduced dosing of Ocaliva in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), while reiterating the importance of close monitoring of PBC patients for progression of their disease and the occurrence of liver-related adverse reactions.

Actions to Enhance Education About Appropriate Use of Ocaliva

Patient safety is Intercept’s highest priority and it is imperative that Ocaliva is dosed according to its approved label. In addition to the DHCP letter, Intercept has taken actions to enhance education about appropriate use of Ocaliva. These initiatives include:

  • reeducating physicians on the label, with a focus on ensuring appropriate dosing for patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis);
  • enhancing monitoring of patients for liver-related adverse reactions; and
  • completing adjudication of all reported cases of serious liver injury, including in patients with no or mild hepatic impairment.

Pursuant to the FDA’s safety communication, Intercept has begun working with the FDA on updates to the label to better ensure appropriate and safe use of Ocaliva.

Shares of Intercept Pharmaceuticals closed on Friday at $61.59, down $12.11 or -16.43%. ICPT has a 1-year high of $172.75 and a 1-year low of $60.97. The stock’s 50-day moving average is $104.04 and its 200-day moving average is $114.73.

On the ratings front, ICPT has been the subject of a number of recent research reports. In a report issued on September 22, Cowen analyst Ritu Baral reiterated a Buy rating on ICPT, with a price target of $112, which represents a potential upside of 82% from where the stock is currently trading. Separately, on the same day, Morgan Stanley’s Andrew Berens maintained a Sell rating on the stock and has a price target of $50.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Andrew Berens have a yearly average return of 23.2% and 15.7% respectively. Baral has a success rate of 54% and is ranked #62 out of 4653 analysts, while Berens has a success rate of 69% and is ranked #476.

Sentiment on the street is mostly bullish on ICPT stock. Out of 14 analysts who cover the stock, 7 suggest a Buy rating , 5 suggest a Hold and 2 recommend to Sell the stock. The 12-month average price target assigned to the stock is $157.9, which represents a potential upside of 156% from where the stock is currently trading.

Intercept is a biopharmaceutical company, which engages in the research, development, and commercialization of novel therapeutics in treating chronic liver diseases. Its product pipeline is OCALIVA which is used for the treatment of primary biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis, and biliary atresia.


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