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.

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.

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.”