The heart fail­ure mar­ket gets a lit­tle more crowd­ed, as Eli Lil­ly and Boehringer In­gel­heim score a win for Jar­diance

Watch out, Farx­i­ga: There’s an­oth­er SGLT2 in­hibitor ap­proved to treat heart fail­ure pa­tients with re­duced ejec­tion frac­tion (HFrEF).

On Wednes­day, Eli Lil­ly and Boehringer In­gel­heim se­cured a win for Jar­diance in HFrEF, a con­di­tion where the mus­cle of the left ven­tri­cle doesn’t pump nor­mal­ly. The in­di­ca­tion ac­counts for more than half of heart fail­ure pa­tients, and the risk of death in­creas­es with each hos­pi­tal­iza­tion, ac­cord­ing to the part­ners.

In the Phase III EM­PER­OR-Re­duced tri­al, Jar­diance on top of stan­dard of care was shown to re­duce the risk of the pri­ma­ry com­pos­ite end­point of time to car­dio­vas­cu­lar death or hos­pi­tal­iza­tion for heart fail­ure by 25% com­pared to stan­dard of care alone, Lil­ly and Boehringer In­gel­heim said. The tri­al en­rolled 3,730 adults with and with­out Type 2 di­a­betes who had a left ven­tric­u­lar frac­tion of 40% or less.

Car­dio­vas­cu­lar death or hos­pi­tal­iza­tion oc­curred in 19.4% of pa­tients in the treat­ment arm, com­pared to 24.7% of those who re­ceived a place­bo, with a p-val­ue of less than 0.001, the com­pa­nies said.

The drug will com­pete with Farx­i­ga, which As­traZeneca claims was the first SGLT2 in­hibitor proven to sig­nif­i­cant­ly re­duce the risk of death and hos­pi­tal­iza­tion due to heart fail­ure. SGLT2 drugs were ini­tial­ly de­vel­oped for di­a­betes, and work by curb­ing the ab­sorp­tion of glu­cose via the kid­neys so that sur­plus glu­cose is ex­cret­ed through uri­na­tion.

Farx­i­ga snagged an ap­proval for HFrEF pa­tients last May, based on da­ta which showed the drug plus stan­dard of care re­duced the risk of car­dio­vas­cu­lar death or wors­en­ing of heart fail­ure by 26% com­pared to just the stan­dard of care.

There’s al­so No­var­tis’ En­tresto — a com­bi­na­tion of neprilysin in­hibitor sacu­bi­tril and an­giotensin re­cep­tor II block­er val­sar­tan — which is ap­proved to treat not on­ly HFrEF, but al­so heart fail­ure pa­tients with pre­served ejec­tion frac­tion (HF­pEF), when the heart pumps nor­mal­ly but is too stiff to fill prop­er­ly.

En­tresto had a rocky road to ap­proval, af­ter fail­ing to meet the pri­ma­ry end­point in a Phase III tri­al. How­ev­er, the FDA urged No­var­tis to pur­sue its ap­pli­ca­tion any­way, ar­gu­ing the study’s de­sign may have pro­duced mis­lead­ing re­sults, and high­light­ing re­sults from pre-spec­i­fied fol­low-up analy­ses that point­ed to sig­nif­i­cant ben­e­fits.

Lil­ly, Boehringer and As­traZeneca are all gun­ning for ap­provals in HF­pEF, with the for­mer read­ing out pos­i­tive re­sults for Jar­diance last month. Jar­diance aced the pri­ma­ry end­point in a piv­otal out­comes tri­al in heart fail­ure pa­tients with a pre­served ejec­tion frac­tion (HF­pEF) with or with­out Type 2 di­a­betes, cut­ting the com­pos­ite risk of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion com­pared with place­bo, the part­ners an­nounced.

Mean­while, As­traZeneca is cur­rent­ly run­ning a more than 6,200-pa­tient Phase III study for Farx­i­ga in HF­pEF, which is ex­pect­ed to wrap in ear­ly 2022.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”