As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA re­cent­ly spurned an ap­pli­ca­tion to al­low As­traZeneca’s block­buster drug Farx­i­ga for type 1 di­a­betes that can­not be con­trolled by in­sulin, cit­ing safe­ty con­cerns — the US reg­u­la­tor has en­dorsed the use of the SGLT2 treat­ment to re­duce the risk of hos­pi­tal­i­sa­tion for heart fail­ure in pa­tients with type-2 di­a­betes and es­tab­lished car­dio­vas­cu­lar dis­ease or mul­ti­ple CV risk fac­tors.

Farx­i­ga is the first SGLT2 in the Unit­ed States to se­cure ap­proval in this pa­tient pop­u­la­tion, As­traZeneca in­di­cat­ed on Mon­day.

Pa­tients with di­a­betes are of­ten af­flict­ed with oth­er co­mor­bidi­ties, such as obe­si­ty, CV dis­ease, and kid­ney prob­lems. SGLT2 mak­ers have been clam­or­ing for a broad­er mar­ket share by dif­fer­en­ti­at­ing their drugs on the ba­sis of ther­a­peu­tic im­pact on these in­ter­sect­ing in­di­ca­tions — but the ma­jor, most lu­cra­tive bat­tle­ground is the heart.

The ap­proval em­anates from da­ta tab­u­lat­ed in the DE­CLARE-TI­MI 58 study, which tracked the CV im­pact of Farx­i­ga ver­sus a place­bo over a pe­ri­od of up to five years in more than 17,000 adults. In the tri­al, the ther­a­py hit one of two pri­ma­ry ef­fi­ca­cy end­points.

The re­sults showed that the Farx­i­ga treat­ment did trig­ger a low­er rate of hos­pi­tal­iza­tion for heart fail­ure — but the ther­a­py was not bet­ter or worse than place­bo in its im­pact on the rate of ma­jor ad­verse car­dio­vas­cu­lar events (MACE), de­fined as car­dio­vas­cu­lar death, my­ocar­dial in­farc­tion, or is­chemic stroke.

On the pri­ma­ry goal of MACE — 8.8% of Farx­i­ga pa­tients and 9.4% in the place­bo group suf­fered MACE events (haz­ard ra­tio: 0.93; P=0.17), al­though the dif­fer­ence was not deemed sta­tis­ti­cal­ly sig­nif­i­cant. On the oth­er end­point, Farx­i­ga did re­sult in a low­er rate of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion for heart fail­ure (4.9% in the Farx­i­ga arm vs. 5.8% on the place­bo group; P=0.005), which re­flect­ed a low­er rate of hos­pi­tal­iza­tion for heart fail­ure (haz­ard ra­tio, 0.73); there was no be­tween-group dif­fer­ence in car­dio­vas­cu­lar death.

The FDA ap­proval fol­lows a sim­i­lar up­date to the drug’s la­bel by the EMA  in Au­gust.

Farx­i­ga, akin to In­vokana from J&J $JNJ and Jar­diance from Eli Lil­ly $LLY, be­longs to a class of di­a­betes drugs called sodi­um-glu­cose co-trans­porter 2 (SGLT2) in­hibitors, which work by curb­ing the ab­sorp­tion of glu­cose via the kid­neys so that sur­plus glu­cose is ex­cret­ed through uri­na­tion. Al­though the class of drugs is unit­ed by sim­i­lar­i­ties, In­vokana’s la­bel is crip­pled with the risk of am­pu­ta­tion, un­like Jar­diance and Farx­i­ga.

In Sep­tem­ber, As­traZeneca un­veiled da­ta from the DA­PA-HF tri­al, which showed the drug cut the risk of CV death or the wors­en­ing of heart fail­ure in pa­tients with heart dis­ease.

The 4,744-pa­tient tri­al test­ed Farx­i­ga in pa­tients with re­duced ejec­tion frac­tion (HFrEF) — in which the heart mus­cle is not able to con­tract am­ply and, there­fore, ex­pels less oxy­gen-rich blood in­to the body — on stan­dard of care treat­ment, in­clud­ing those with and with­out type-II di­a­betes.

Farx­i­ga re­duced the com­pos­ite end­point of car­dio­vas­cu­lar (CV) death or wors­en­ing of heart fail­ure by 26% (p<0.0001) — in­clud­ing a re­duc­tion in each of the in­di­vid­ual com­po­nents of the end­point. Da­ta showed there was a 30% de­crease (p<0.0001) in the risk of ex­pe­ri­enc­ing a first episode of wors­en­ing heart fail­ure and an 18% cut (p=0.0294) in the risk of death from car­dio­vas­cu­lar caus­es.

Farx­i­ga, which was ap­proved for use in type-II di­a­betes back in 2014 — whose sales un­der­whelmed an­a­lyst ex­pec­ta­tions in the sec­ond quar­ter — is al­so be­ing eval­u­at­ed for pa­tients with heart fail­ure in the DE­LIV­ER (HF­pEF) and DE­TER­MINE (HFrEF and HF­pEF) tri­als, in ad­di­tion to chron­ic kid­ney dis­ease in the DA­PA-CKD tri­al. Its ri­vals are test­ing their di­a­betes of­fer­ings in a range of heart and kid­ney tri­als as well.

Late last month, the FDA ex­pand­ed In­vokana’s la­bel to slow the pro­gres­sion of di­a­bet­ic nephropa­thy (DKD), as well as to re­duce the risk of hos­pi­tal­iza­tion for heart fail­ure in pa­tients with type II di­a­betes and DKD — an in­di­ca­tion that no oth­er type II di­a­betes med­i­cine is ap­proved for.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

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Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

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The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

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Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

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President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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