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.

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.

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.

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 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.