Merdad Parsey, Gilead CMO

FDA slaps a hold on Gilead­'s in­jectable HIV treat­ment over con­cerns about po­ten­tial glass con­t­a­m­i­nants

The FDA is com­ing down on yet an­oth­er ther­a­py over con­cerns about glass par­tic­u­lates wind­ing up in drug so­lu­tion.

Reg­u­la­tors have slapped a clin­i­cal hold on 10 tri­als study­ing in­jectable ver­sions of Gilead’s ex­per­i­men­tal HIV treat­ment lenaca­pavir, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of sub-vis­i­ble glass par­ti­cles in the so­lu­tion.

“We are com­mit­ted to work­ing dili­gent­ly with FDA to re­solve this glass vial com­pat­i­bil­i­ty qual­i­ty is­sue and re­sume in­jectable lenaca­pavir dos­ing in the af­fect­ed stud­ies in a time­ly fash­ion,” CMO Mer­dad Parsey said in a state­ment.

The dos­ing of oral for­mu­la­tions will con­tin­ue, ac­cord­ing to Gilead, and in­ves­ti­ga­tors will con­tin­ue mon­i­tor­ing the pa­tients who have al­ready been dosed with in­jectable for­mu­la­tions, as well as dose par­tic­i­pants in com­para­tor arms.

Gilead’s been work­ing on lenaca­pavir, an HIV-1 cap­sid in­hibitor, for both the treat­ment and pre­ven­tion of HIV-1 in­fec­tion. While most an­tivi­rals act on just one stage of vi­ral repli­ca­tion, the com­pa­ny says lenaca­pavir is de­signed to in­hib­it HIV-1 at mul­ti­ple stages of its life­cy­cle.

The drug is Gilead’s big next-gen an­tivi­ral. Back in March, the com­pa­ny signed a co-de­vel­op­ment pact to study the can­di­date in com­bi­na­tion with Mer­ck’s is­la­travir.

How­ev­er, Mer­ck slammed the brakes on its pro­gram in No­vem­ber af­ter in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to is­la­travir. The FDA placed an of­fi­cial clin­i­cal hold on the ex­per­i­men­tal treat­ment ear­li­er this month.

The clin­i­cal hold af­fects sev­er­al mid- and late-stage tri­als, in­clud­ing one Phase III as­sess­ing pre-ex­po­sure pro­phy­lax­is in cis­gen­der men, trans­gen­der women, trans­gen­der men, and gen­der non-bi­na­ry peo­ple 16 years or old­er; and an­oth­er Phase III look­ing at pre-ex­po­sure pro­phy­lax­is in ado­les­cent girls and young women in com­bi­na­tion with stan­dards of care emtric­itabine/teno­fovir alafe­namide.

This isn’t the first time Gilead has run in­to trou­ble with glass par­tic­u­lates. Ear­li­er this month, the phar­ma com­pa­ny re­called two lots of its Covid-19 treat­ment Vek­lury af­ter the ap­pear­ance of par­tic­u­lates. A cus­tomer com­plaint had been con­firmed by a Gilead in­ves­ti­ga­tion.

Over the last year, glass par­tic­u­lates have emerged as an in­dus­try-wide prob­lem. Back in Oc­to­ber, one lot of Mer­ck’s an­tibi­ot­ic Cu­bicin was re­called af­ter a piece of glass was found in a vial, rais­ing safe­ty con­cerns. And in June, the FDA is­sued a warn­ing let­ter to the Japan­ese man­u­fac­tur­er Toy­obo Co af­ter 12 batch­es of in­jecta­bles were found to have cel­lu­lose and glass fibers, stains, and par­ti­cles on vials, the FDA said.

This month, the FDA re­leased draft guid­ance aim­ing to help drug­mak­ers pre­vent the risk of par­tic­u­late con­t­a­m­i­na­tion.

While side ef­fects caused by the glass pieces de­pend on the route of ad­min­is­tra­tion, the pa­tient pop­u­la­tion, and the na­ture of the par­tic­u­lates them­selves (such as size or shape), the agency not­ed that some pa­tients could ex­pe­ri­ence in­fec­tion, ve­nous or ar­te­r­i­al blood clots, in­flam­ma­tion, or even em­boli, ab­scess­es, and gran­u­lo­mas in vis­cer­al or­gans.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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UP­DAT­ED: FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.