The second HIV-prevention injectable of 2021 has been approved by the FDA

An 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 HJIV, 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.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.

The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.

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A young man with Duchenne muscular dystrophy has died in Pfizer’s Phase Ib trial of its mini-dystrophin gene therapy, triggering a halt in screening and dosing — and a clinical hold imposed by the FDA.

Pfizer informed the Parent Project Muscular Dystrophy of the death in a community letter. The patient was participating in the non-ambulatory cohort of the trial, the company wrote, adding:

At this time, we do not yet have complete information and are actively working with the trial siteinvestigator to understand what happened.

Angie You and Volker Schellenberger, Amunix

Sanofi is crashing the year-end M&A party with a deal of its own.

Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’

‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’

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Graphic: Alexander Lefterov for Endpoints News

Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.

In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.

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Aldeyra Therapeutics’ shares tanked in premarket trading after the company admitted its dry eye candidate reproxalap missed the primary endpoint in a topline Phase III readout — but who needs the primary?

Despite the late-stage failure, Aldeyra is charging ahead with another Phase III trial, and CEO Todd Brady is confident a secondary endpoint will lead the candidate to success.

‘We continue to advance reproxalap toward NDA submission as we focus on the completion of TRANQUILITY-2 and enrollment in the 12-month safety trial,’ he said in a statement.

The director of the gastrointestinal oncology program at the University of Chicago Medical Center has been charged by the US attorney in Chicago with insider trading after he made more than $134,000 from stock trades based on an early look at the results of a Five Prime Therapeutics trial.

The US attorney’s office said yesterday that back in early November 2020, Daniel Catenacci, a University of Chicago associate professor with more than a decade of experience who worked with Five Prime on early trials, purchased more than 8,700 shares of the company the morning before it announced positive results from a Phase II trial in treating advanced gastric/gastroesophageal cancer.

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Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.

Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.

One of Pfizer’s new vaccine TV commercials never mentions its vaccine brand Comirnaty. In fact, it doesn’t mention vaccines or Covid-19 at all and doesn’t show people wearing masks or social distancing. Yet it’s clear the ad is talking about the pharma’s Covid-19 vaccines.

The ad’s voiceover talks about the unremarkable moments and routines that matter, like getting a coffee refill at a diner or Sunday grocery shopping. The images shift from those everyday moments to a scientists and purple lidded glass vials spinning off a production line and being packed into freezers.
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