As­traZeneca's block­buster Farx­i­ga se­cures land­mark ap­proval in heart fail­ure pa­tients, re­gard­less of whether they have di­a­betes

Last Oc­to­ber, the FDA cleared the use of As­traZeneca’s block­buster ther­a­py Farx­i­ga to re­duce the risk of hos­pi­tal­iza­tion for heart fail­ure in pa­tients with type 2 di­a­betes and es­tab­lished car­dio­vas­cu­lar dis­ease or CV risk fac­tors. Now, the US agency has opened up the use of the di­a­betes drug in an even big­ger pop­u­la­tion: to re­duce the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure in all pa­tients, even those that don’t have di­a­betes.

Pa­tients with di­a­betes are of­ten af­flict­ed with oth­er co­mor­bidi­ties, such as obe­si­ty, CV dis­ease, and kid­ney prob­lems. SGLT2 drug 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.

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 and with­out type 2 di­a­betes) with re­duced ejec­tion frac­tion — in which the heart mus­cle is not able to con­tract am­ply and, there­fore, ex­pels less oxy­gen-rich blood in­to the body — in ad­di­tion to stan­dard-of-care treat­ment.

John Mc­Mur­ray

“The ground-break­ing re­sults of the DA­PA-HF tri­al have trans­formed heart fail­ure ther­a­peu­tics. To­day’s ap­proval pro­vides physi­cians with a com­plete­ly nov­el phar­ma­co­log­i­cal ap­proach that great­ly im­proves out­comes for pa­tients with heart fail­ure with re­duced ejec­tion frac­tion,” said John Mc­Mur­ray from the In­sti­tute of Car­dio­vas­cu­lar and Med­ical Sci­ences, Uni­ver­si­ty of Glas­gow, in a state­ment.

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, 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.

Farx­i­ga was ini­tial­ly ap­proved for use in type 2 di­a­betes back in 2014 — it gen­er­at­ed more than $1.5 bil­lion in sales last year.

In late March, the British drug­mak­er wrapped up a late-stage study test­ing the drug in a chron­ic kid­ney dis­ease pop­u­la­tion af­ter reg­is­ter­ing “over­whelm­ing ef­fi­ca­cy” in pa­tients, re­gard­less of type 2 di­a­betes sta­tus — in the Unit­ed States alone, that’s a mar­ket of rough­ly 30 mil­lion pa­tients. With the ex­plo­sion of coro­n­avirus cas­es across the globe, the com­pa­ny is al­so test­ing Farx­i­ga as a po­ten­tial ther­a­py to re­duce or­gan fail­ure in Covid-19 pa­tients.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.

Neil Desai, Aadi Bioscience CEO (Specialised Therapeutics via YouTube)

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

SPACs have become the preferred fast track for public markets over the past year, but apparently there’s still room for a good, old-fashioned reverse merger.

Cancer-focused Aadi Bioscience announced Monday that they would merge with the struggling public biotech Aerpio Pharmaceuticals. To go along with the merger, Aadi raised $155 million from private investors to commercialize their lead drug, Fyarro, which is now sitting before the FDA. Acuta Capital Partners and KVP Capital led the round.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.