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Intercept Pharmaceuticals, Inc. ICPT announced that the prescribing information for lead drug, Ocaliva (obeticholic acid or OCA), in the United States has been updated.
OCA is approved under the brand name, Ocaliva, for treating primary biliary cholangitis (PBC) 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 update to the prescribing information was prompted by cases submitted to the FDA’s Adverse Event Reporting System and published in the medical literature. These were cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva.
Consequently, the Boxed Warning has been updated and Ocaliva is now contraindicated for patients with PBC and decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis with evidence of portal hypertension.
Since these new updates to the Ocaliva Prescribing Information include important additional warnings and precautions for the targeted patient population (patients with PBC and cirrhosis who may be at risk of experiencing liver-related side effects), sales might take a hit.
Intercept generated sales of $81.7 million in the first quarter.
Shares of the company have lost 33.8% in the year so far compared with the industry’s decline of 4.9%.
In anticipation of the label update, Intercept narrowed its sales guidance concurrent with the first-quarter earnings. Ocaliva net sales are projected between $325 million and $340 million (earlier projection: $325-$355 million for 2021).
OCA is also being evaluated for NASH. Earlier, Intercept received a setback when the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for OCA to treat fibrosis due to NASH. The CRL for OCA was disappointing as the candidate was a frontrunner in receiving approval for the treatment of NASH.
While the NASH market promises potential, it is quite challenging as well. Bigwigs like Novo Nordisk NVO and Gilead Sciences, Inc. GILD are also evaluating candidates for NASH. Another company, Viking Therapeutics VKTX, is enrolling in the phase IIb VOYAGE study to evaluate VK2809 for biopsy-confirmed NASH and fibrosis.
Intercept currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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