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Covid-19 roundup: FDA au­tho­rizes Pfiz­er-BioN­Tech boost­er for 12-to-15-year-olds; Ear­ly re­sults sug­gest an­tivi­rals may hold up against Omi­cron

Chil­dren be­tween the ages of 12 and 15 years old are now el­i­gi­ble for a third dose of the Pfiz­er-BioN­Tech vac­cine af­ter the FDA au­tho­rized it Mon­day, as well as a third shot for those be­tween 5 and 11 who are im­muno­com­pro­mised.

The FDA al­so short­ened the time be­tween the com­ple­tion of a pri­ma­ry vac­cine and a boost­er shot to five months for Pfiz­er’s jab, al­though Mod­er­na’s boost­er in­ter­val re­mains at 6 months. The moves come as Omi­cron has ripped through the US, caus­ing the num­ber of pos­i­tive cas­es to sky­rock­et.

“Through­out the pan­dem­ic, as the virus that caus­es Covid-19 has con­tin­u­ous­ly evolved, the need for the FDA to quick­ly adapt has meant us­ing the best avail­able sci­ence to make in­formed de­ci­sions with the health and safe­ty of the Amer­i­can pub­lic in mind,” act­ing FDA Com­mis­sion­er Janet Wood­cock said in a state­ment.

The ex­pand­ed boost­er EUA comes af­ter re­view­ing re­al-world da­ta in Is­rael, in­clud­ing safe­ty da­ta from 6,300 peo­ple be­tween the ages of 12 and 15. All got a boost­er at least five months af­ter the orig­i­nal two dos­es. There were no new safe­ty con­cerns af­ter a boost­er shot, and there were no new cas­es of my­ocardi­tis or peri­cardi­tis re­port­ed. — Josh Sul­li­van

Ear­ly re­sults sug­gest an­tivi­rals may hold up against Omi­cron

As the Omi­cron vari­ant — now dom­i­nant in the US — threat­ens the ef­fi­ca­cy of cur­rent­ly avail­able vac­cines and mon­o­clon­al an­ti­bod­ies, new da­ta sug­gest that three an­tivi­rals may hold up against the mu­ta­tion.

Gilead’s remde­sivir, Mer­ck’s mol­nupi­ravir and Pfiz­er’s Paxlovid will like­ly re­tain their ac­tiv­i­ty against all cur­rent vari­ants of con­cern, in­clud­ing Omi­cron, as the tar­get pro­teins of these an­tivi­rals are high­ly con­served, ac­cord­ing to re­sults from a new study post­ed on bioRx­iv.

It’s im­por­tant to note that these re­sults are from a preprint, and have not been peer-re­viewed or pub­lished in a jour­nal.

“These re­sults in­di­cate that when more VOCs arise, due to anti­genic drift, there is a high prob­a­bil­i­ty that they will re­main sen­si­tive to­wards cur­rent an­tivi­rals,” the preprint states. “It is there­fore im­por­tant to con­tin­ue both vac­cine de­vel­op­ment as well as an­tivi­ral re­search, as they are both es­sen­tial ar­mor and com­ple­ment each oth­er in the strat­e­gy to con­trol the cur­rent pan­dem­ic.”

While remde­sivir was the first FDA-au­tho­rized an­tivi­ral to treat Covid-19 (and is ad­min­is­tered via IV), two oral op­tions from Mer­ck and Pfiz­er got the green light just a cou­ple of weeks ago. Pfiz­er’s at-home pill, sold com­mer­cial­ly as Paxlovid, proved to re­duce the rel­a­tive risk of hos­pi­tal­iza­tion or death by 89% (with­in three days of symp­tom on­set) and 88% (with­in five days of symp­tom on­set) com­pared to place­bo in a tri­al of more than 2,000 peo­ple.

Mer­ck’s pill, on the oth­er hand, saw its ef­fi­ca­cy drop from a 50% rel­a­tive re­duc­tion in hos­pi­tal­iza­tions and deaths at the in­ter­im read­out to just 30% in the fi­nal re­sults. And un­like the Pfiz­er pill, mol­nupi­ravir is not rec­om­mend­ed for use dur­ing preg­nan­cy.

The news comes as two mAb treat­ments from Re­gen­eron and Eli Lil­ly are not ef­fec­tive against Omi­cron, and sup­plies of a third mAb from Vir/Glax­o­SmithK­line are very lim­it­ed.

“Though the cur­rent fo­cus lies on SARS-CoV-2, we wish to em­pha­size the need for broad-spec­trum an­tivi­rals for fu­ture vi­ral out­breaks,” the preprint states. — Nicole De­Feud­is 

Bel­gium inks deals for 2 an­tivi­ral pills

As gov­ern­ments are mov­ing to buy Pfiz­er’s an­tivi­ral pill, Bel­gium has reached an agree­ment to buy 10,000 cours­es, Reuters re­port­ed.

The coun­try will al­so buy 10,000 cours­es of Mer­ck’s mol­nupi­ravir. That drug has gone through ups and downs, with France can­cel­ing its or­der for the drug as re­cent­ly as De­cem­ber af­ter some less-than-im­pres­sive tri­al da­ta. But Bel­gian health work­ers have ad­vised that its coun­try pur­chase 10,000 cours­es of both Paxlovid and mol­nupi­ravir.

In the US, the FDA’s an­timi­cro­bial drugs ad­vi­so­ry com­mit­tee vot­ed 13-10 in fa­vor of the pill’s ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms, in No­vem­ber. But it took the FDA un­til Dec. 23 to au­tho­rize the pill.

Paxlovid re­quires a six pill dai­ly reg­i­men, with three pills in the morn­ing and an­oth­er three at night. Mol­nupi­ravir re­quires four in the morn­ing and an­oth­er four at night. Nei­ther drug has been au­tho­rized by Eu­ro­pean drug agen­cies, though the EMA did say that it was OK to use Paxlovid for adults who don’t re­quire sup­ple­men­tal oxy­gen. In a con­ver­sa­tion with Reuters, the spokesper­son did not re­veal de­tails about the cost of these deals. — Josh Sul­li­van

Pfiz­er’s Covid-19 pill gets OK in Britain 

Pfiz­er’s Covid-19 pill, dubbed Paxlovid, has got­ten the OK in Britain for use in adults who have mild to mod­er­ate in­fec­tion and at least one un­der­ly­ing con­di­tion that could lead to se­vere ill­ness, such as obe­si­ty, old­er age, di­a­betes mel­li­tus or heart dis­ease.

Be­cause Paxlovid has shown to be most ef­fec­tive dur­ing the ear­ly stages of in­fec­tion, the coun­try’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency rec­om­mends that pa­tients take it with­in five days of the start of their symp­toms.

The MHRA cleared the drug on Dec. 31, adding that it’s too ear­ly to tell whether Omi­cron will im­pact its ef­fi­ca­cy.

The pill was au­tho­rized by the FDA a cou­ple of weeks ago. And while the agency not­ed in its EUA health care provider fact sheet that Paxlovid should stand up against the Omi­cron vari­ant, most of the tri­al da­ta has on­ly been re­leased in Pfiz­er press re­leas­es so far.

“We now have a fur­ther an­tivi­ral med­i­cine for the treat­ment of COVID-19 that can be tak­en by mouth rather than ad­min­is­tered in­tra­venous­ly,” June Raine, MHRA chief ex­ec­u­tive, said in a state­ment. “I hope the an­nounce­ment to­day gives re­as­sur­ance to those par­tic­u­lar­ly vul­ner­a­ble to COVID-19, for whom this treat­ment has been ap­proved. For these in­di­vid­u­als, this treat­ment could be life-sav­ing.” — Nicole De­Feud­is 

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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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.

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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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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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.

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.