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New York, N.Y., March 25, 2024 – PRISM MarketView – Drug development is an arduous, costly and time-consuming process for the teams involved behind the scenes, and the patients anxiously awaiting breakthroughs in different disease areas. It takes 12 years on average for a company to take a drug from discovery to commercialization, and every hard-won FDA approval is a cause for celebration for researchers, companies and the end-users whose lives may be changed by these treatments.

The past few years have seen numerous regulatory successes for biopharmaceutical companies. In 2020, the FDA approved 53 new molecular entities, and in 2021, 55 new drugs were approved, including multiple COVID-19 vaccines and Biogen’s controversial Alzheimer’s disease treatment, Aduhelm. In 2022 that number dropped to 37, but included TG Therapeutics’ BRIUMVI for relapsing forms of Multiple Sclerosis. 2023 saw approvals rise to an impressive 66 new drugs, which included Qalsody for ALS, Leqembi for Alzheimer’s disease and the postpartum depression drug, Zurzuvae.

Six drugs have already received a nod from the FDA in 2024, and there are a handful of hotly anticipated therapeutics waiting in the wings. PRISM MarketView takes a look at the year’s successes and what we can expect to see in the coming months.

  1. ZELSUVMI™, Ligand Pharmceuticals’ treatment for molluscum contagiosum in adults and pediatric patients, was approved in the first week of the year. ZELSUVMI is the first novel drug for the treatment of molluscum, a highly contagious viral skin infection.
  1. Discovered by Indian pharmaceuticals company, and commercialized by privately-held Allecra Therapeutics, Exblifep was granted FDA approval for the treatment of complicated urinary tract infections in February.
  1. Also in February, Korean toxin manufacturer Hugel won FDA approval for Letybo, described as the leading neurotoxin brand in South Korea, and a direct competitor to Allergan’s Botox, to improve the appearance of moderate-to-severe glabellar (frown) lines.
  1. Tevimbra, a BeiGene and Novartis  collaboration, received a regulatory nod for the treatment of patients with unresectable or metastatic esophageal squamous cell carcinoma. The treatment was found to be safer than chemotherapy, with manageable adverse effects.
  1. Last week, Madrigal Pharmaceuticals’ Rezdiffra won FDA approval, becoming the first and only drug to be approved for the advanced liver disease, metabolic dysfunction-associated steatohepatitis (MASH).
  1. This week, Swiss biotech, Idorsia  was granted FDA approval for Tryvio, a once-daily treatment to reduce hypertension, in combination with other antihypertensive drugs in adults.

Drugs anticipated to cross the FDA finish line in 2024 include Karuna Therapeutics’ KarXT for schizophrenia. The drug’s Prescription Drug User Fee Amendments (PDUFA) action date is set for September 2024 and if approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades.

Eli Lilly’s Donanemab for Alzheimer’s disease has demonstrated significant slowing of cognitive and functional decline in people with early symptomatic Alzheimer’s disease in Phase 3 studies. The company expects to have a decision from the FDA in the first quarter of 2024. Finally, ImmunityBio’s  Anktiva for nonmuscle invasive bladder cancer is approaching its PDUFA date – April 23 – when it expects a final decision from the FDA.

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