FDA ap­proves Re­by­ota, Fer­ring's poop-based drug to fight C. diff in­fec­tion

The FDA ap­proved Fer­ring Phar­ma­ceu­ti­cals’ Re­by­ota drug on Wednes­day, a poop-based drug im­plant that can pre­vent the re­cur­rence of Clostrid­ioides dif­fi­cile in­fec­tion.

While the use of fe­cal mi­cro­bio­ta trans­plan­ta­tion (FMT) — re­plen­ish­ing a pa­tient’s gut with bac­te­ria from healthy fe­ces — has al­ready been hap­pen­ing with­out an FDA-ap­proved prod­uct, Re­by­ota is the first live bio­ther­a­peu­tic drug ap­proved by the agency to fight the po­ten­tial­ly dead­ly in­fec­tion.

Swiss drug­mak­er Fer­ring first bought Re­bi­otix, the start­up work­ing on the drug, in 2018. In Sep­tem­ber, Re­by­ota faced a pan­el of the FDA’s out­side ex­perts who rec­om­mend­ed its use.

Re­by­ota works by re­pop­u­lat­ing the gut mi­cro­bio­me. The trans­plant­ed mi­crobes then fight with the C. diff in­fec­tion, pre­vent­ing it from grow­ing and forc­ing it out of the gut.

The drug has been ap­proved for peo­ple 18 years of age and old­er who have al­ready com­plet­ed an­tibi­ot­ic treat­ment for C. diff in­fec­tions that con­tin­ue to come back.

Clostrid­ioides dif­fi­cile is a bac­te­ria that caus­es life-threat­en­ing di­ar­rhea. It is usu­al­ly a side ef­fect of tak­ing an­tibi­otics long term and can eas­i­ly spread from per­son to per­son. The in­fec­tion oc­curs most of­ten in peo­ple 65 and old­er who take an­tibi­otics, those stay­ing in hos­pi­tals and nurs­ing homes for a long pe­ri­od of time and in peo­ple with weak­ened im­mune sys­tems.

In clin­i­cal tri­als, the over­all es­ti­mat­ed rate of suc­cess in pre­vent­ing re­cur­rent CDI through eight weeks was sig­nif­i­cant­ly high­er in the Re­by­ota group (70.6%) than in the place­bo group (57.5%).

Safe­ty has been a key con­cern with in­tro­duc­ing donor fe­cal mat­ter in­to a per­son’s mi­cro­bio­me. Pri­or to Fer­ring’s Phase III an­nounce­ment, the FDA had flagged the po­ten­tial risk of se­ri­ous or life-threat­en­ing in­fec­tions with FMT.

The agency sev­er­al days ago al­so re­cent­ly tight­ened its en­force­ment pol­i­cy around FMT, not­ing, “FDA does not in­tend to ex­tend en­force­ment dis­cre­tion with re­spect to the IND re­quire­ments for dis­tri­b­u­tion of FMT prod­ucts ob­tained from stool banks.”

Fer­ring is not the on­ly com­pa­ny try­ing to break in­to the poop-based drug land­scape, but the on­ly one suc­cess­ful with the FDA so far.

In March 2022, the FDA slapped a clin­i­cal hold on Finch Ther­a­peu­tics’ test­ing of oral “crap­sules” that al­so use bac­te­ria strains ex­tract­ed from donor stool in or­der to treat C. diff, over fears that stool sam­ples might be able to trans­mit SARS-CoV-2 be­tween pa­tients. The hold was even­tu­al­ly lift­ed in April. Seres Ther­a­peu­tics is al­so de­vel­op­ing a mi­cro­bio­me treat­ment for C. diff. In Oc­to­ber, the FDA gave a PDU­FA date of April 26, and ac­cord­ing to the biotech, the agency is not plan­ning on an ad­comm.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed to note that Re­by­ota is the first live bio­ther­a­peu­tic to fight C diff, not the first drug ap­proved to fight this in­fec­tion.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.