As­traZeneca COPD drug fi­nal­ly gets OK from FDA, inch­ing clos­er to GSK leader

Al­most a year ago, As­traZeneca’s triple-drug com­bi­na­tion for chron­ic ob­struc­tive pul­monary dis­ease was shot down with an FDA com­plete re­sponse let­ter. But on Fri­day, it fi­nal­ly re­ceived the green light.

The UK phar­ma gi­ant has re­ceived ap­proval for its Breztri Aeros­phere, for­mer­ly dubbed PT010, cul­mi­nat­ing the drug’s bumpy reg­u­la­to­ry jour­ney in a win. Now, As­traZeneca can chal­lenge the leader in the area — Glax­o­SmithK­line’s Trel­e­gy — with­out ob­sta­cle.

Orig­i­nal­ly, Breztri Aeros­phere faced con­cerns from the re­sults of its KRO­NOS tri­al. De­spite demon­strat­ing pos­i­tive topline re­sults, the in­haler drug failed to sig­nif­i­cant­ly dis­tin­guish it­self from two of As­traZeneca’s oth­er dual-com­bo ther­a­pies in the rate of mod­er­ate or se­vere COPD ex­ac­er­ba­tions.

But As­traZeneca re­turned to reg­u­la­tors with re­sults from the more re­cent ETHOS study, which had not been com­plet­ed when the phar­ma orig­i­nal­ly sub­mit­ted the NDA. That ex­ac­er­ba­tion rate served as ETHOS’ pri­ma­ry end­point as op­posed to KRO­NOS, which mea­sured lung func­tion pa­ra­me­ters.

“Pre­vent­ing ex­ac­er­ba­tions is cen­tral to the man­age­ment of chron­ic ob­struc­tive pul­monary dis­ease,” said Fer­nan­do Mar­tinez, lead in­ves­ti­ga­tor of the ETHOS tri­al, in a state­ment. “Even a sin­gle ex­ac­er­ba­tion can have a neg­a­tive im­pact on a pa­tient’s lung func­tion and qual­i­ty of life, and it can in­crease the risk of death.”

Full re­sults from ETHOS, re­leased last Au­gust, in­di­cat­ed that both stan­dard and half dos­es of the ther­a­py’s budes­onide agent re­sult­ed in sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in those COPD ex­ac­er­ba­tions. Ad­di­tion­al­ly, ETHOS was a 52-week tri­al where­as KRO­NOS was 24 weeks.

Breztri Aeros­phere had pre­vi­ous­ly re­ceived a reg­u­la­to­ry OK in Japan with num­bers from the KRO­NOS study, but the FDA was not sat­is­fied.

The ther­a­py it­self com­bines its pre­vi­ous dual-com­bi­na­tion treat­ments in­to what As­traZeneca has said is a bet­ter way for pa­tients to in­di­vid­u­al­ly cal­i­brate their dosage lev­els. In ad­di­tion to the in­haled cor­ti­cos­teroid budes­onide, Breztri Aeros­phere uti­lizes a LAMA (gly­copy­rro­ni­um) and a LA­BA (for­moterol fu­marate).

Giv­en the ap­proval, GSK could face some stiffer com­pe­ti­tion in the COPD mar­ket. Trel­e­gy is al­so a triple-com­bo ther­a­py and raked in about $660 mil­lion in 2019 sales, with al­most three-quar­ters of that amount com­ing from US pur­chas­es. As the res­pi­ra­to­ry field shifts to­ward triple-drug com­bi­na­tions and away from dual- and monother­a­py treat­ments, As­traZeneca is look­ing to take a chunk of that pie.

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.

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.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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.