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Intercept (ICPT) NDA for NASH Treatment Gets CRL From FDA
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Intercept Pharmaceuticals, Inc. announced that the FDA issued a complete response letter (CRL) in response to the company’s new drug application (NDA) seeking approval for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
The FDA indicated in the CRL that the NDA cannot be approved in its present form following a review.
The NDA resubmission will require successful completion of the long-term outcomes phase of the REGENERATE study per the content of the CRL.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver, inducing chronic inflammation and resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Consequently, Intercept has decided to discontinue all NASH-related investments and restructure its operations to strengthen its focus on rare and serious liver diseases.
The CRL was expected as the FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting had voted against the approval of the NDA for OCA for the treatment of pre-cirrhotic fibrosis due to NASH in May. The FDA had publicly posted briefing documents prior to the meeting due to concerns about drug-induced liver injury. The document stated that, during the review, the FDA identified modest benefits and serious risks of OCA for treating NASH.
Intercept’s shares have lost 8.2% in the year so far compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
Intercept had earlier received a CRL from the FDA in 2020 stating that its NDA for OCA, for treating liver fibrosis due to NASH, could not be approved in its present form.
The CRL indicated that the FDA determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for treating patients with liver fibrosis due to NASH.
The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue. Thereafter, in January 2023, the FDA accepted the NDA, indicating its consideration of this as a complete Class 2 resubmission.
The successful development of OCA for NASH would have been a significant boost for the company.
We note that OCA is already approved under the brand name Ocaliva for treating primary biliary cholangitis (in combination with ursodeoxycholic acid [UDCA]) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
The NASH market holds potential but is quite challenging with no approved therapies.
Several other companies are attempting to develop a treatment for the same condition.
Madrigal Pharmaceuticals, Inc.'s (MDGL - Free Report) resmetirom has received Breakthrough Therapy designation from the FDA for treating patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES.
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
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Intercept (ICPT) NDA for NASH Treatment Gets CRL From FDA
Intercept Pharmaceuticals, Inc. announced that the FDA issued a complete response letter (CRL) in response to the company’s new drug application (NDA) seeking approval for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
The FDA indicated in the CRL that the NDA cannot be approved in its present form following a review.
The NDA resubmission will require successful completion of the long-term outcomes phase of the REGENERATE study per the content of the CRL.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver, inducing chronic inflammation and resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Consequently, Intercept has decided to discontinue all NASH-related investments and restructure its operations to strengthen its focus on rare and serious liver diseases.
The CRL was expected as the FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting had voted against the approval of the NDA for OCA for the treatment of pre-cirrhotic fibrosis due to NASH in May. The FDA had publicly posted briefing documents prior to the meeting due to concerns about drug-induced liver injury. The document stated that, during the review, the FDA identified modest benefits and serious risks of OCA for treating NASH.
Intercept’s shares have lost 8.2% in the year so far compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
Intercept had earlier received a CRL from the FDA in 2020 stating that its NDA for OCA, for treating liver fibrosis due to NASH, could not be approved in its present form.
The CRL indicated that the FDA determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for treating patients with liver fibrosis due to NASH.
The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue. Thereafter, in January 2023, the FDA accepted the NDA, indicating its consideration of this as a complete Class 2 resubmission.
The successful development of OCA for NASH would have been a significant boost for the company.
We note that OCA is already approved under the brand name Ocaliva for treating primary biliary cholangitis (in combination with ursodeoxycholic acid [UDCA]) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
The NASH market holds potential but is quite challenging with no approved therapies.
Several other companies are attempting to develop a treatment for the same condition.
Madrigal Pharmaceuticals, Inc.'s (MDGL - Free Report) resmetirom has received Breakthrough Therapy designation from the FDA for treating patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES.
Intercept currently has a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Ligand Pharmaceuticals (LGND - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.