Race for first-to-market NASH therapy heats up, says GlobalData

Following the FDA’s announcement to review Intercept Pharmaceuticals’ resubmission of its new drug application (NDA) for obeticholic acid (OCA) in patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH);

Sravani Meka, Senior Immunology Analyst at GlobalData, a leading data and analytics company, offers her view:

“The race for a first-to-market therapy in NASH has been a marathon with many companies facing numerous setbacks and failures. However, it appears that two companies have gained momentum in recent times and are in a sprint to the finish line. Leading the race to commercialization are Intercept Pharmaceuticals’s OCA, and Madrigal Pharmaceuticals’ resmetirom (selective thyroid hormone receptor-β agonist; THR-Beta agonist).

“It is unsurprising that the FDA has requested an advisory committee (AdCom) meeting in May 2023 given its rejection of Intercept’s OCA in NASH NDA in 2020, further compounded by the recent negative topline results from the company’s Phase III REVERSE trial (NCT03439254) evaluating OCA in patients with compensated cirrhosis due to NASH. However, the impending AdCom could be a silver lining for the company, as it could provide it with an opportunity to highlight the additional efficacy and safety data from the ongoing pivotal Phase III REGENERATE trial and assuage any concerns from the FDA about the failed safety data from the Phase III REVERSE trial.

“Madrigal Pharmaceuticals’ resmetirom appears to be closing Intercept’s lead in the race to market for the first approved therapy in NASH in the US. Recent steps taken by the company, including the announcement of intentions to file for an NDA seeking accelerated approval of resmetirom in H1 2023, followed by the presentation of positive data reinforcing the positive primary endpoint results, show the company’s strong intent to bring on its ‘A’ game to win the race.

“With the race for a first-to-market therapy in NASH reaching a significant stage, the strategic efforts from both companies have raised the profile of NASH, an indication that is in dire need of an approved therapy. And while the first-to-market therapy for NASH will have its own accolades, it is possible that both candidates, with their different MOAs and benefit-risk profiles, can co-exist in the NASH market.”

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