Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa via AP Images)

As­traZeneca's big CKD promis­es come to fruition as Farx­i­ga wins ap­proval in pa­tients re­gard­less of di­a­betes sta­tus

Al­most a year af­ter nab­bing a ground­break­ing ap­proval for heart fail­ure pa­tients with or with­out type 2 di­a­betes, As­traZeneca’s Farx­i­ga claimed an­oth­er no­table OK on Fri­day.

The SGLT2 in­hibitor got the FDA green light for chron­ic kid­ney dis­ease in adults at risk of pro­gres­sion, the British phar­ma said late Fri­day af­ter­noon. Much like the heart fail­ure ap­proval, Fri­day’s win is al­so in­di­cat­ed for pa­tients re­gard­less of if they have type 2 di­a­betes. Farx­i­ga was orig­i­nal­ly ap­proved to treat type 2 di­a­betes back in 2014.

Mene Pan­ga­los

The drug is now the first in its class to treat CKD re­gard­less of di­a­betes sta­tus, a move R&D chief Mene Pan­ga­los hailed in a state­ment as “the most sig­nif­i­cant ad­vance­ment in the treat­ment of chron­ic kid­ney dis­ease in more than 20 years.”

Farx­i­ga has proved to be one of As­traZeneca’s biggest sell­ers, grow­ing by 30% last year when it to­taled near­ly $2 bil­lion in sales. Though it hit the mar­ket af­ter J&J ri­val In­vokana, Farx­i­ga man­aged to eat up a large por­tion of the SGLT2 pie af­ter In­vokana was hit with a black box warn­ing for an in­creased risk of am­pu­ta­tion.

The ex­pand­ed la­bel al­so puts Farx­i­ga well ahead of Eli Lil­ly and Boehringer In­gel­heim’s com­peti­tor Jar­diance, which isn’t ex­pect­ed to read out CKD da­ta un­til next year at the ear­li­est.

As­traZeneca had been drum­ming up ex­cite­ment for the drug ever since they wrapped up their CKD tri­al ear­ly in March 2020, when they claimed “over­whelm­ing ef­fi­ca­cy.” They fol­lowed that up with da­ta in Au­gust, which showed Farx­i­ga re­duced car­dio­vas­cu­lar or re­nal mor­tal­i­ty and the wors­en­ing of re­nal func­tion by 39% com­pared to place­bo. Farx­i­ga al­so re­duced the risk of death from any cause by 31%.

Its dataset proved to be im­pres­sive enough to nab the FDA’s break­through ther­a­py des­ig­na­tion in Oc­to­ber, and pri­or­i­ty re­view in Jan­u­ary. And ex­plorato­ry analy­ses from one of its Phase III stud­ies re­port­ed­ly showed the drug can be ef­fec­tive in CKD pa­tients with less se­vere dis­ease, the British drug­mak­er claimed.

Fri­day’s ap­proval will open up Farx­i­ga to a mar­ket of about 37 mil­lion pa­tients in the US, As­traZeneca says.

Though the phar­ma has an­chored a turn­around pri­mar­i­ly on its on­col­o­gy port­fo­lio, CEO Pas­cal So­ri­ot has long made it a goal to ex­pand Farx­i­ga from di­a­betes in­to oth­er dis­eases. That am­bi­tion has large­ly proven suc­cess­ful over the last two years or so, first with the heart fail­ure ap­proval and now Fri­day’s CKD win.

Farx­i­ga, like its SGLT2 in­hibitor com­pa­tri­ots, works by tar­get­ing a pro­tein in the kid­neys that af­fects how the body re­ab­sorbs glu­cose. By block­ing the SGLT2 pro­tein, the drugs low­er re­ab­sorp­tion and con­se­quent­ly low­er blood sug­ar lev­els.

The full in­di­ca­tion for CKD al­lows Farx­i­ga to be used to re­duce the risk of sus­tained es­ti­mat­ed glomeru­lar fil­tra­tion rate (eGFR) de­cline, end-stage kid­ney dis­ease (ES­KD), car­dio­vas­cu­lar (CV) death and hos­pi­tal­iza­tion for heart fail­ure (hHF) in adults with the dis­ease.

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.

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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.

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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.

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.

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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.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.