Cheap SS­RI drug proves suc­cess­ful in re­duc­ing Covid-re­lat­ed hos­pi­tal­iza­tion times in large tri­al

An­oth­er weapon against Covid-19 could be made more promi­nent as re­sults from a large, place­bo-con­trolled tri­al pub­lished in the Lancet on Wednes­day evening pro­vide com­pelling ev­i­dence that the cheap SS­RI flu­vox­am­ine may re­duce Covid-re­lat­ed hos­pi­tal­iza­tion times.

Of the 741 par­tic­i­pants who re­ceived flu­vox­am­ine in the tri­al in Brazil, 79, or 10.6%, re­quired an ex­tend­ed stay for more than six hours in an emer­gency set­ting or hos­pi­tal­iza­tion, com­pared to 119 out of the 756 (15.7%) par­tic­i­pants who re­ceived place­bo.

The cheap and read­i­ly avail­able se­lec­tive sero­tonin re­up­take in­hibitor, typ­i­cal­ly used to treat de­pres­sion or OCD, could quick­ly join the ranks of oth­er out­pa­tient treat­ments like mon­o­clon­al an­ti­bod­ies, or Mer­ck’s hot­ly an­tic­i­pat­ed an­tivi­ral mol­nupi­ravir.

The au­thors from Brazil­ian uni­ver­si­ties and Mc­Mas­ter Uni­ver­si­ty in On­tario wrote:

Our tri­al has found that flu­vox­am­ine, an in­ex­pen­sive ex­ist­ing drug, re­duces the need for ad­vanced dis­ease care in this high-risk pop­u­la­tion. A 10-day course of flu­vox­am­ine costs ap­prox­i­mate­ly US$4 even in well re­sourced set­tings. Our study com­pares favourably with the treat­ment ef­fects of more ex­pen­sive treat­ments in­clud­ing mon­o­clon­al an­ti­bod­ies for out­pa­tient treat­ment. The ab­solute num­ber of se­ri­ous ad­verse events as­so­ci­at­ed with flu­vox­am­ine was low­er than for place­bo and this might re­flect the mod­u­la­to­ry ef­fect of flu­vox­am­ine on sys­temic in­flam­ma­tion in these par­tic­i­pants.

David Boul­ware

David Boul­ware of the Uni­ver­si­ty of Min­neso­ta Med­ical School, who was un­af­fil­i­at­ed with the tri­al, told End­points News via email of the re­sults, “the out­comes were bet­ter among those who could tol­er­ate the med­i­cine, where the most com­mon side ef­fects were gas­troin­testi­nal in na­ture. Among those who took at least 80% of the flu­vox­am­ine, there was a two-thirds re­duc­tion in hos­pi­tal­iza­tions or ER vis­its – as well as deaths be­ing re­duced by 90% with on­ly one death in the flu­vox­am­ine [arm of the tri­al] ver­sus 12 with place­bo.”

The tri­al was de­signed and done in part­ner­ship with lo­cal pub­lic health au­thor­i­ties from 11 cities in Brazil to si­mul­ta­ne­ous­ly test po­ten­tial treat­ments for ear­ly dis­ease via a mas­ter pro­to­col. Mas­ter pro­to­cols have long been fa­vorites of top FDA and NIH lead­ers like Janet Wood­cock and Fran­cis Collins.

Pre­vi­ous­ly, a tri­al in the US of a high­er dose of flu­vox­am­ine (100 mg three times a day for 15 days) in­clud­ed a low­er risk group for the pri­ma­ry out­come but found no cas­es among 80 pa­tients re­ceiv­ing flu­vox­am­ine ver­sus six cas­es among 72 pa­tients re­ceiv­ing place­bo, ac­cord­ing to the Lancet pa­per. A large ob­ser­va­tion­al study from France al­so showed a re­duc­tion in the use of in­tu­ba­tion or death with the use of SS­RIs among 7,230 hos­pi­tal­ized Covid-19 pa­tients.

There are still two US tri­als in­ves­ti­gat­ing a low­er flu­vox­am­ine dose of 50 mg twice dai­ly which would have few­er side ef­fects and be more tol­er­a­ble, ac­cord­ing to Boul­ware.

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh’s Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy & Pre­scrib­ing and al­so un­af­fil­i­at­ed with the tri­al, told End­points that this is “a re­al­ly im­por­tant tri­al show­ing again the pow­er of these adap­tive plat­form tri­als. The big ques­tions were stat­ed at the end of the ed­i­to­r­i­al: what does this mean for vac­ci­nat­ed peo­ple, and how does this fit in terms of oth­er ther­a­pies we now have, like mon­o­clon­al an­ti­bod­ies and mol­nupi­ravir. The drug again high­lights the im­por­tance of ear­ly and quick di­ag­no­sis, which is re­quired to get peo­ple med­ica­tions as ear­ly as pos­si­ble.”

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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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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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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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.