FDA approvals drop in 2024, Transcarent acquires Accolade

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The US Food and Drug Administration closed out 2024 with the approval of 50 new drugs, ending a wave of long-awaited treatments.

That's according to the agency's official tally of new treatments not previously approved or marketed in the United States. The total drugs removed was down slightly from 55 in 2023, but there were several firsts and other high-profile drugs that the agency gave the green light last year.

This includes the first-ever treatment for metabolic syndrome-associated steatohepatitis (MASH), a common and potentially fatal liver disease that affects millions worldwide. The medicine Rezdiffra is from Madrigal PharmaceuticalsWhich has now succeeded in a disease field that many major companies have failed or are still trying to break into.

The FDA also approved the first two treatments for a rare progressive genetic disorder called Niemann-Pick disease type C. This condition causes damage to the nervous system over time because the body cannot properly transport cholesterol and other fatty substances within cells, resulting in damage to the nervous system. . Accumulation of these substances in the body.

The agency granted the first approval for a drug called Miplyffa Zefra treatmentswhich reached the finish line on a second attempt after a previous rejection in 2021. Privately held IntraBio's Aqneursa also received FDA approval to treat Niemann-Pick disease type C.

Last year, the US Food and Drug Administration (FDA) also approved several drugs designed to treat familiar diseases in new ways.

For example, Bristol Myers SquibbCobenfy is the first new treatment approved for schizophrenia in decades. It is the first drug of a new class that does not directly block dopamine to improve symptoms.

PfizerThe company's new drug for treating hemophilia A or B, a hereditary bleeding disorder drug, is also the first to target a specific protein in the blood clotting process. Hympavzi treatment is also the first hemophilia medication approved in the United States and is specifically administered using a prefilled auto-injector pen.

MerckWinrevair becomes the first drug to target the root cause of pulmonary arterial hypertension, a progressive and life-threatening lung condition. Other medications available only help manage symptoms.

Meanwhile, the US Food and Drug Administration approved AmgenImdelltra treatment, as a second or subsequent line of treatment for people with advanced small cell lung cancer. This is the first and only treatment called T-cell therapy approved for this deadly type of lung cancer.

Amgen's drug is specifically designed to redirect T cells in the immune system to recognize and kill cancer cells.

Other notable FDA approvals include Eli LillyThe long-awaited drug to treat early symptoms of Alzheimer's disease has faced many hurdles on its way to the market. The treatment, Kisonla, expands the limited treatment options in the United States for the disease that causes mental degeneration.

Notably, many of the FDA approvals were for products from a mix of little-known public and private companies, such as Allecra Therapeutics, Yovannes Biotherapy and BridgeBio Pharma. It suggests that small biotech companies are more willing to bring their products to market on their own rather than partnering with or acquiring a large pharmaceutical company.

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Digital health startup Transcarent announced Wednesday that it will acquire the company badge In a deal valued at approximately $621 million.

Transcarent, which earned a spot on CNBC's Disruptor 50 list last year, offers at-risk pricing models to self-insured employers to help their workers quickly access care and navigate benefits. As of May, the company had raised about $450 million at a valuation of $2.2 billion.

Accolade provides caregiving, navigation and advocacy services. The company went public during the coronavirus pandemic in 2020 as investors began pouring billions of dollars into digital health, but the stock has mostly been in free fall in the years since. Accolade is the latest in a string of digital health companies to exit public markets as the sector resets post-Covid.

Transcarent said it will acquire Accolade for $7.03 per share in cash, representing a premium of about 110% over its closing stock price on Tuesday. The deal is expected to close next quarter, although it is still subject to shareholder and regulatory approvals.

“By combining Transcarent’s complex care experience with Accolade’s employees and 16 years of healthcare data, we will create a more personalized healthcare experience for people while improving outcomes and lowering costs,” Accolade CEO Rajeev Singh said in a statement on Wednesday.

Evercore served as financial advisor to Transcarent for the transaction. Morgan Stanley advised Accolade.

Transcarent CEO Glenn Tolman is no stranger to flashy deals in digital health. Tolman previously ran Livongo, which was acquired by virtual care company Teladoc in a 2020 agreement that valued the company at $18.5 billion.

When Teladoc acquired Livongo, the companies had a combined value of $37 billion. Teladoc's market cap is now about $1.7 billion.

“Since Livongo, I think there has been some loss of energy in terms of the power of digital healthcare,” Tolman told CNBC in an interview on Wednesday. “We are now creating an experience that people not only love, but actually love.”

Transcarent and Accolade have “very similar visions,” Tolman said. Accolade has established experience in medical opinions, primary care and patient advocacy services, for example, which he said Transcarent's client base seeks out.

“I think it was a perfect fit,” Tolman said.

Read the full release here.

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