NATIONAL NEWS

First pill for fecal transplant wins FDA approval

Apr 26, 2023, 3:42 PM

This photo provided by Seres Therapeutics shows manufacturing equipment for oral microbiome therape...

This photo provided by Seres Therapeutics shows manufacturing equipment for oral microbiome therapeutic capsules in the company's Cambridge, Mass., facility in May 2022. On Wednesday, April 26, 2023, U.S. health officials approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants. (Genevieve de Manio/Seres Therapeutics via AP)
Credit: ASSOCIATED PRESS

(Genevieve de Manio/Seres Therapeutics via AP)

WASHINGTON (AP) — U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants.

The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help hard-to-treat patients.

The Food and Drug Administration cleared the capsules for adults who may have trouble fighting off Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea.

C. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment.

More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections.

The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via colonoscopy.

Cambridge Massachusetts-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days.

Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut.

Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country.

While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open.

OpenBiome, the largest stool bank in the U.S., said it will keep serving patients who aren’t eligible for the FDA-approved products, such as children and adults with treatment-resistant cases. It has supplied more than 65,000 stool samples for C. diff patients since 2013.

“OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr. Majdi Osman, the group’s medical chief.

OpenBiome’s standard stool treatment costs less than $1,700 and is typically delivered as a frozen solution within days of ordering. Seres has not disclosed what price it would set for its capsules.

“We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the company’s chief financial officer, in an interview ahead of the announcement. “Ease of administration — in our view — is one of the aspects of the value we’re delivering.”

Seres will co-market the treatment with Swiss food giant Nestle, which will also split the profits.

Overseeing the fledgling industry of U.S. stool banks has created regulatory headaches for the FDA, which doesn’t traditionally police homemade products and procedures used in doctor’s offices. In the early days of the trend, the FDA warned consumers about the risks of potential infections from the fecal transplants, as some people sought out questionable “do it yourself” methods from videos and websites.

Seres executives say their manufacturing process relies on the same techniques and equipment used to purify blood products and other biologic therapies.

The company starts with stool provided by a small group of donors who are screened for various health risks and conditions. Their stool is likewise tested for dozens of potential viruses, infections and parasites.

The company then processes the samples to remove the waste, isolate the healthy bacteria and kill any other lingering organisms. Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, according to the company.

The FDA warned in a release Wednesday that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted.

The FDA approved the treatment based on a 180-patient study in which 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.

Common side effects included abdominal swelling, constipation and diarrhea.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter ___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

National News

Associated Press

US official says Biden’s meeting with Netanyahu remains on track, despite withdrawal from race

WASHINGTON (AP) — Israeli Prime Minister Benjamin Netanyahu will meet with President Joe Biden at the White House this week as planned, despite Biden’s withdrawal from the presidential race, a person familiar with Biden’s schedule said Sunday. The official, speaking on condition of anonymity because they were not authorized to comment publicly, said the exact […]

52 minutes ago

FILE - President Joe Biden participates in a briefing in the Oval Office of the White House, Dec. 2...

Associated Press

Biden’s legacy: Far-reaching accomplishments that didn’t translate into political support

WASHINGTON (AP) — Sitting in the Oval Office behind the iconic Resolute desk in 2022, an animated President Joe Biden described the challenge of leading a psychologically traumatized nation. The United States had endured a life-altering pandemic. There was a jarring burst of inflation and now global conflict with Russia invading Ukraine, as well as […]

2 hours ago

Associated Press

Here’s the letter that Biden wrote to say he would no longer seek reelection

WASHINGTON (AP) — Preident Joe Biden on Sunday posted a letter to social media announcing that he would no longer seek reelection. The decision by the Democrat came after building pressure from lawmakers, donors, activists and voters within his own party who had concerns about his ability to beat Republican Donald Trump in November’s election. […]

2 hours ago

Associated Press

Democrats hail Biden’s decision to not seek reelection as selfless. Republicans urge him to resign

WASHINGTON (AP) — Democratic lawmakers hailed President Joe Biden’s historic decision on Sunday not to seek reelection, praising him as putting his country and his party before himself. Republicans called on him to resign from office, saying that if he could not run for another term, office, then he’s unable to serve as president. Biden’s […]

2 hours ago

FILE - Vice President Kamala Harris speaks in the East Room of the White House, March 18, 2024, in ...

Associated Press

Harris, endorsed by Biden, could become first woman, second Black person to be president

WASHINGTON (AP) — She’s already broken barriers, and now Kamala Harris could become the first Black woman to head a major party presidential ticket after President Joe Biden abruptly ended his reelection bid and endorsed her. Biden announced Sunday that was stepping aside amid widespread concerns about the viability of his candidacy. Harris is the […]

2 hours ago

Image: Vice President Kamala Harris, left, and President Joe Biden attend a trilateral meeting in t...

Associated Press

What happens next: Biden wants to pass the baton to Harris. How that might work

As President Joe Biden ends his reelection bid and endorses Vice President Kamala Harris, Democrats must navigate an unprecedented shift.

3 hours ago

First pill for fecal transplant wins FDA approval