FDA clears first long-act­ing HIV-pre­ven­tion in­jectable, giv­ing Vi­iV claim to his­toric OK

A long-act­ing in­jectable treat­ment for the pre­ven­tion of HIV has been giv­en the go-ahead by the FDA for use in adults and chil­dren weigh­ing at least 77 pounds.

Apre­tude is first giv­en as two in­jec­tions giv­en a month apart from each oth­er, and then every two months af­ter. Pa­tients are giv­en the op­tion to start treat­ment with Apre­tude or the oral cabote­gravir Vo­cabria for four weeks to as­sess how well to tol­er­ate the drug.

“To­day’s ap­proval adds an im­por­tant tool in the ef­fort to end the HIV epi­dem­ic by pro­vid­ing the first op­tion to pre­vent HIV that does not in­volve tak­ing a dai­ly pill,” FDA di­rec­tor of an­tivi­rals De­bra Birnkrant said. “This in­jec­tion, giv­en every two months, will be crit­i­cal to ad­dress­ing the HIV epi­dem­ic in the U.S., in­clud­ing help­ing high-risk in­di­vid­u­als and cer­tain groups where ad­her­ence to dai­ly med­ica­tion has been a ma­jor chal­lenge or not a re­al­is­tic op­tion.”

About 25% of the 1.2 mil­lion peo­ple for which pre-ex­po­sure pro­phy­lax­is was rec­om­mend­ed were pre­scribed the treat­ment for HIV pre­ven­tion in the US in 2020, a num­ber up from about 3% in 2015, the FDA said. But that re­quires “high lev­els of ad­her­ence,” and the FDA hopes that the ap­proval of Arep­tude will help in­crease up­take in high-risk pa­tients.

Two safe­ty and ef­fi­ca­cy tri­als were eval­u­at­ed: Tri­al 1 in HIV-un­in­fect­ed men and trans­gen­der women who have sex with men and have high-risk be­hav­ior for HIV in­fec­tion, and Tri­al 2 in un­in­fect­ed cis­gen­der women who were at risk of ac­quir­ing HIV.  Par­tic­i­pants in tri­al 1 had 69% less risk of get­ting HIV, and those in tri­al 2 had a 90% risk re­duc­tion.

Par­tic­i­pants who took Apre­tude start­ed the tri­al with 30 mg of cabote­gravir tak­en oral­ly, and a place­bo each day for up to five weeks. That was fol­lowed by a 600mg in­jec­tion of Apre­tude at months one and two, then every two months af­ter and a dai­ly place­bo tablet.

Par­tic­i­pants who didn’t take Apre­tude were giv­en Tru­va­da and start­ed the tri­al tak­ing Tru­va­da and a place­bo dai­ly for up to five weeks, fol­lowed by a com­bi­na­tion of Tru­va­da and a place­bo in­jec­tion.

This Jan­u­ary, the FDA al­so ap­proved Cabe­nu­va, a com­bi­na­tion of cabote­gravir and in­jectable rilpivirine, as a com­plete reg­i­men for the treat­ment of HIV-1 in pa­tients with no known or sus­pect­ed re­sis­tance to the drugs. That was the first-ever ap­proved in­jectable by the FDA ap­proved for adults in­fect­ed with HIV and is ad­min­is­tered once a month. Vo­cabria, which is the tablet for­mu­la­tion of cabote­gravir, was al­so ap­proved by the FDA to be tak­en with Edu­rant oral­ly for a month be­fore treat­ment starts, to en­sure that the treat­ment will be well-tol­er­at­ed. Both drugs were pre­vi­ous­ly grant­ed fast track and pri­or­i­ty re­view des­ig­na­tion from the FDA.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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