FDA Watch: The Most Impactful Drug Approvals in 2024

The FDA approved 55 drugs in 2023, including the highly anticipated Lecanemab by Eisai (ESAIY) and Biogen (BIIB), GSK’s (GSK) world-first vaccine for respiratory syncytial virus (RSV), Zurzuvae, the first oral postpartum depression treatment by Biogen and Sage Therapeutics (SAGE), and Pfizer’s (PFE) Velsipity for ulcerative colitis.

15 drugs have now received a nod from the regulator, including some with significant life-changing potential. PRISM MarketView takes a look at the four new drugs that are expected to be the most impactful this year.

Amneal Pharmaceuticals (AMRX): Naloxone hydrochloride for opioid overdose

Last month, Amneal was granted FDA approval for its OTC nasal spray (naloxone hydrochloride) for the emergency treatment of opioid overdose. The product is a generic equivalent to OTC NARCAN® and is indicated in heroin, fentanyl and prescription opioid medication overdoses. Amneal is targeting a significant market opportunity: NARCAN sales for the 12 months ended February 2024 totaled $266 million. Amneal’s share price is currently $6.76 and the company has a market cap of $2.08 billion.

Vanda Pharmaceuticals (VNDA): Fanapt for bipolar I disorder

In April, Vanda Pharmaceuticals received FDA approval for Fanapt as a treatment for manic or mixed episodes in bipolar I disorder. The company’s share price surged 30.4% following the news, with investors pleased with the potentially significant commercial opportunity. Fanapt, a familiar therapeutic agent, has been approved in the US for the treatment of schizophrenia since 2009. Since the FDA’s decision, Vanda has received and rejected several unsolicited takeover proposals from Future Pak since March 2024, concluding that they “significantly undervalue the company”. Vanda’s share price sits at $4.88 and it has a market cap of $284 million.

Neurocrine Biosciences (NBIX): Ingrezza for Huntington’s Disease

Last week, Neurocrine received approval from the FDA for Ingrezza in a SPRINKLE capsule formulation for the treatment of Huntington’s disease. The new oral granules formulation provides an alternative dosing strategy for those who have difficulty swallowing. Ingrezza was previously approved in capsule form in 2017 for tardive dyskinesia, a side effect of antipsychotic medications, and subsequently for unpredictable muscle movements (chorea) in Huntington’s disease last year. Severe chorea can affect a person’s ability to eat and drink. Neurocrine has a share price of $140.71, and its market cap stands at $14.16 billion.

Takeda (TAK): Entyvio for Crohn’s disease

Also in April, the FDA approved the subcutaneous administration of ENTYVIO® (vedolizumab) in a single-dose prefilled pen for maintenance therapy in active Crohn’s disease. The drug is now available in intravenous and subcutaneous administrations in the US. Takeda reported that a statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every two weeks achieved long-term clinical remission. Crohn’s disease affects between six and eight million people worldwide. Takeda’s share price is currently $13.37 and its market cap is $42.28 billion.