Fewer New Drugs Approved by FDA in 2024, but Some Big Ones Launched

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In 2024, the U.S. Food and Drug Administration approved 50 new drugs, marking the end of a long-awaited wave of treatments.

In 2023, the number of new treatments approved by the agency decreased slightly from 55 to 54. However, there were several first-time and noteworthy medications that received the agency's approval last year.

Rezdiffra, the first-ever treatment for metabolic dysfunction-associated steatohepatitis (MASH), has been developed by a company that has successfully entered a disease area that several large companies have failed in or are still trying to break into.

The FDA approved the first two treatments for Niemann-Pick disease type C, a rare genetic disorder that damages the nervous system over time due to the body's inability to transport cholesterol and other fatty substances inside cells, resulting in a buildup of those substances in the body.

In 2021, the agency granted the first approval to Miplyffa, a drug developed by IntraBio, for the treatment of Niemann-Pick disease type C.

In 2020, the FDA approved several drugs for treating familiar diseases through novel methods.

Schizophrenia has been treated with a new drug called Cobenfy, which is the first novel treatment approved in decades. Unlike other drugs in its class, Cobenfy does not directly block dopamine to improve symptoms.

Hympavzi, a new drug for hemophilia A or B, is the first to target a specific protein in the blood-clotting process. It is also the first hemophilia medicine approved in the U.S. that is specifically administered using a pre-filled, auto-injector pen.

Winrevair is the first drug to address the underlying cause of pulmonary arterial hypertension, a severe and fatal lung disease. Unlike other medications, which merely alleviate symptoms, Winrevair targets the root cause.

The FDA approved Imdelltra, a T-cell engager therapy, as a second or later line treatment for people with advanced small-cell lung cancer. This makes it the first and only such therapy approved for this deadly form of lung cancer.

Amgen's drug targets T-cells to identify and eliminate cancer cells.

The FDA has approved Kisunla, a drug for early symptomatic Alzheimer's disease, which faced several challenges in its journey to market. This treatment is expanding the limited treatment options in the U.S. for the disease that causes mental degeneration.

The FDA has approved many products from a mix of small public and private companies, such as Allecra Therapeutics, Biotherapeutics, and Pharma. This suggests that smaller biotech companies are increasingly willing to bring their products to market independently, rather than partnering or getting acquired by large pharmaceutical companies.

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Latest in health-care tech: Transcarent to take Accolade private for $621 million

On Wednesday, Transcarent announced the acquisition of a digital health startup in a deal worth approximately $621 million.

Transcarent, a company that made it onto CNBC's Disruptor 50 list last year, offers self-insured employers at-risk pricing models to help their workers quickly access care and navigate benefits. By May, the company had raised approximately $450 million at a valuation of $2.2 billion.

Accolade provides care delivery, navigation, and advocacy services. The company went public in 2020 during the coronavirus pandemic, but its stock has mostly been declining since then. Accolade is the latest in a series of digital health companies to leave the public markets as the sector adjusts after Covid.

Transcarent will receive $7.03 per share in cash for Accolade, which is a 110% premium over its Tuesday closing stock price. The deal is expected to close in the next quarter, but is subject to shareholder and regulatory approvals.

Rajeev Singh, CEO of Accolade, stated on Wednesday that by combining Transcarent's intricate care experience with Accolade's people and 16 years of healthcare data, we will provide a more personalized healthcare experience for individuals while improving outcomes and reducing costs.

Transcarent had Evercore as its financial adviser for the deal, while Accolade was advised by Morgan Stanley.

Glen Tullman, CEO of Transcarent, has experience with flashy deals in the digital health industry. He previously led Livongo, which was acquired by Teladoc in a 2020 deal worth $18.5 billion.

Teladoc's market cap is now roughly $1.7 billion after acquiring Livongo, which had a combined enterprise value of $37 billion.

"Tullman stated in an interview with CNBC on Wednesday that there was a loss of energy regarding the power of digital health care since Livongo. However, he added that they are now creating an experience that people not only like but genuinely love."

Tullman stated that Transcarent and Accolade share "similar visions." Transcarent's client base has sought Accolade's established expertise in medical opinions, primary care, and patient advocacy services, which Accolade provides.

"I think this was a perfect fit," Tullman said.

Read the full release here.

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