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Intercept Pharmaceuticals, Inc.

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FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC

NEW YORK, Dec. 17, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic, underserved liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29, 2016 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.

Intercept is seeking approval of OCA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
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Source: press release, 12/17/15. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=947530

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Mark Pruzanski, M.D., CEO & President, commented on the upcoming advisory committee for OCA. He stated, "In August, we announced that the FDA granted priority review for OCA in PBC, with a PDUFA date of February 29, 2016. We are pleased that the FDA has been very engaged with us in the review process and we continue to expect and are preparing for an advisory committee meeting early next year. Keep in mind that OCA, if approved, will be the first new medicine for PBC in 20 years. We are also continuing our regulatory process in Europe and continue to plan for approval and launch in the second half of 2016."
Source: Q3 2015 earnings conference call, 11/09/15.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Obeticholic acid (OCA) PBCGastroenterologyPrimary Biliary Cirrhosis (PBC)Farnesoid X Receptor (FXR) AgonistFarnesoid X Receptor (FXR)

Mechanism of action: Obeticholic acid (OCA) is a bile acid analog and first-in-class Farnesoid X Receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, or CDCA.

Phase of Development: N/A

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-04-07

Results:

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FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva™ (obeticholic acid) for the Treatment of PBC

PDUFA Date is May 29, 2016

Intercept to host investor conference call today at 5:30 p.m. ET

NEW YORK, April 07, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva™ (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

"We're pleased that the Advisory Committee strongly supported the approval of Ocaliva for people living with PBC. Today's positive recommendation is an encouraging step for the PBC community," said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. "We'd like to thank the many patients and physicians who took part in the research discussed in today's meeting, as their participation and dedication has been — and remains — instrumental in evolving the treatment paradigm for PBC."

Intercept is seeking accelerated approval of Ocaliva for the treatment of PBC in patients with an inadequate response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the only approved therapy for this disease. While UDCA has a marked impact on clinical outcomes in PBC, a substantial percentage of UDCA-treated patients have a suboptimal response or are intolerant to treatment, leaving them at significantly increased risk of an adverse outcome.

The Advisory Committee's recommendation is based on data from the clinical development program for Ocaliva in PBC, including the Phase 3 POISE trial, which assessed the safety and efficacy of Ocaliva in 216 PBC patients who had an inadequate therapeutic response to, or were unable to tolerate, UDCA. Intercept's New Drug Application (NDA) includes data for 432 PBC patients who have received Ocaliva with an amassed total of 675 patient years of exposure and some patients on therapy for over five years. In accordance with the FDA guidelines for accelerated approval, Intercept is currently enrolling COBALT, a global Phase 4 long-term outcomes trial to confirm the clinical benefit of Ocaliva in people living with PBC.

PBC is a rare chronic liver disease, and if patients are left untreated or have an inadequate response to UDCA therapy, the disease typically progresses to hepatic fibrosis, cirrhosis, liver failure and death unless they receive a liver transplant.

The brand name Ocaliva has been provisionally approved by the FDA and European Medicines Agency, but Ocaliva is an investigational medicine that has not been granted marketing authorization or approval from any regulatory authority.

Conference Call Information
Intercept will host a conference call today, Thursday, April 7, 2016, at 5:30 p.m. ET to discuss the outcome of the Gastrointestinal Drugs Advisory Committee meeting. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) five minutes prior to the start time (no passcode required). A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks.
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Source: press release, 4/07/16. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=964146

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