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FDA approves Madrigal’s Rezdiffra as the first NASH therapy
15 Mar 2024
Clinical ResultDrug ApprovalPhase 2Phase 3
According to GlobalData analysis, Rezdiffra is expected to generate $1bn in global sales in 2027. Image Credit: BlurryMe / Shutterstock.
Madrigal Pharmaceuticals’ RezdiffrRezdiffrairom) has become the first drug to be approved by the US Food and Drug Administration (FDA) as a treatment for noncirrhotic nonalcoholic steatohepatitis (NASH), which is also known as metabolic dysfunction-associated steatohepatitis (MASH).
Madrigal Pharmaceuticalscape has seen multiple disappointments, with multiple companies like AstraZeFood and Drug Administration (FDA)velopment of their Nnoncirrhotic nonalcoholic steatohepatitis (NASH)ointments was the US FDA metabolic dysfunction-associated steatohepatitis (MASH)ation (NDA) for its NASH therapy, obeticholic acid. The agency cited concerns over the therapy’s safety profile, especially the potential risks of causing liver injury and diabetes.
RedzNASHa’s approved use is intended for NASH patients with moderate to advanced liver fibrosAstraZenecato be administered in conjunction with diet and eNASHise. “The approval will allow Madrigal market exclusivity in NAUS FDA two years, alIntercept Pharmaceuticalserate considerable profit”, said Jay NASHl, a Globaobeticholic acidecialising in NASH. According to GlobalData’s patient-based forecast, Rezdiffra is expected to generate $liver injuryl saldiabetes27.
Rezdiffra is a thyroid hormone recepPharmaceutical Technology which helps maintain liver homeostasis and improve lipid metabolism. The therapy will be available in the US in April, and in the last few months, the company has been raising funds to finance the launch and commercialisation of Rezdiffra.
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Rezdiffra’s accelerated approval was based on the results from the Phase III MAESTRO-NASH trial (NCT03900429). The study met its two primary endpoints by showing a significant improvement in disease resolution and liver fibrosis. NASH resolved in 25.9% of patients who received an 80mg dose of Rezdiffra and 29.9% of those taking the 100mg dose without the worsening of fibrosis, compared to the 9.7% of patients in the placebo group. Madrigal expects the 54 month-follow-up data from the trial to support full approval for Rezdiffra.
Xcoverydded that althougFDAezdiffra’s appNSCLC ALK inhibitorALKks a major step forward for the NASH therapeutic space, Madrigal is likely to face competition as more NASH assets get approved, especially from the more efficacious FGF21 analogue drug class in more severe fibrotic NASH patient populations. He also mentioned the next-generation THR-β agonists, such as Viking’s VK2809 that aim to build on Rezdiffra’s success, as significant competitors. The approvals for other NASH therapies are expected from 2027–2030.
Patel also cautioned that Madrigal’s success may not last beyond the two-year exclusivity period. “Patients with less severe NASH will also likely be treated initially with incretin-modulating therapies, like Novo Nordisk’s semaglutide (which is marketed as Ozempic or Wegovy or Rybelsus) or Lilly’s tirzepatide (which is marketed as Zepbound or Mounjaro), even prior to the approval of this drug class for NASH, given the extent of comorbid type 2 diabetes and obesity within the NASH population,” he said.
Rezdiffraon to Novo Nordisk trialling its blockbuster drug as a monotherapy, it is alNASHxploring combinations. For treating NASH, semaglutide is being studied in combination with Akero Therapeutics’ efruxifermin. liver fibrosisAkNASHand Novo reported positive data from the Phase IIb trial shoRezdiffra patients who received the efruxifermin and Ozempic combination trefibrosisad a 65% relative reduction in liver fat in patients withMadrigaldiabetes and liver fibrosis due to NASH, compared to a 10% reduction seen in patiRezdiffraiving only Ozempic. Altimmune’s incretin mimetic, pemvidutide, when trialled as a monotherapy showed a 68.5% relative reduction in liver fat content at 12 weeks in a Phase IIb trial.
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