FDA hands AstraZeneca-Amgen broad approval for asthma antibody, clearing blockbuster path

Mene Pangalos (AstraZeneca via YouTube)

Af­ter last year’s Phase III re­sults, there was lit­tle ques­tion that the FDA would ap­prove Am­gen and As­traZeneca’s long-in­cu­bat­ing an­ti­body for asth­ma, bar­ring any man­u­fac­tur­ing de­lays or shock­ing sta­tis­ti­cal sna­fus. The key ques­tion was how many asth­ma pa­tients would be ap­proved by reg­u­la­tors.

The an­swer was a lot, it turned out. De­spite mixed da­ta in some set­tings, the FDA on Fri­day OK’d teze­pelum­ab for vir­tu­al­ly any pa­tient 12 years or old­er with se­vere asth­ma.

It’s the kind of broad la­bel an­a­lysts ex­pect could cat­a­pult the drug to block­buster sta­tus. For many pa­tients, par­tic­u­lar­ly those with no or low lev­els of an im­mune cell called eosinophils, the Am­gen-As­traZeneca drug will be the on­ly bi­o­log­ic op­tion. Re­gen­eron-Sanofi block­buster Dupix­ent, while ap­proved for many peo­ple with asth­ma, failed in those pa­tients.

Am­gen es­ti­mates that group ac­counts for ap­prox­i­mate­ly 30% of the 1 mil­lion US pa­tients with un­con­trolled se­vere asth­ma.

As­traZeneca R&D chief Mene Pan­ga­los said in a state­ment that the drug ‘has the po­ten­tial to trans­form care for a broad pop­u­la­tion of se­vere asth­ma pa­tients.’

Teze­pelum­ab will be mar­ket­ed as Tezspire. An As­traZeneca spokesper­son said that be­cause the ap­proval came ear­ly — the FDA’s dead­line was in Q1 2022 — a price had not yet been set.

The US ap­proval comes near­ly a full decade af­ter Am­gen and As­traZeneca first signed a broad deal on in­flam­ma­tion, agree­ing to joint­ly de­vel­op and com­mer­cial­ize five dif­fer­ent can­di­dates. One of those drugs, bro­dalum­ab, won FDA ap­proval in 2017 as Siliq for plaque pso­ri­a­sis.

Teze­pelum­ab faced a rock­i­er road. The an­ti­body, which blocks TSLP — a cy­tokine com­mon in the ep­ithe­li­um — ini­tial­ly failed in atopic der­mati­tis, the au­toim­mune dis­ease that made Dupix­ent in­to a block­buster.

The da­ta, though, al­ways looked more promis­ing in asth­ma, where there was al­so a slight­ly less crowd­ed mar­ket. The linch­pin re­sults came a year ago, when the part­ners an­nounced a Phase III tri­al showed the drug sig­nif­i­cant­ly re­duced the num­ber of asth­ma ex­ac­er­ba­tions — or asth­ma at­tacks — com­pared to place­bo.

That was true, as the com­pa­nies demon­strat­ed in de­tailed fol­low-up da­ta that win­ter, for both the broad pop­u­la­tion and for pa­tients with low eosinophils counts, where oth­er drugs failed.

The drug did fail in one tri­al on se­vere asth­ma pa­tients last De­cem­ber, but the com­pa­nies pinned the re­sults on a de­sign flaw. The FDA seems to have agreed that the da­ta over­all point to teze­pelum­ab ben­e­fit.

De­spite the broad la­bel and a mo­nop­oly in a sub­group of pa­tients, an­a­lysts are prepar­ing for a slow com­mer­cial roll­out as Omi­cron be­gins to sweep across the globe. Many new drugs have strug­gled to launch dur­ing the pan­dem­ic.

‘Over­all this is a pos­i­tive … in our view, ap­pre­ci­at­ing that in­vestors will be a bit cau­tious on the launch giv­en the Omi­cron Covid en­vi­ron­ment (new drugs do not launch well these days in these ar­eas, so in­vestors will need pa­tience on a launch),’ Jef­feries an­a­lyst Michael Yee said in a note.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.

The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.

Unlock this story instantly and join 126,100+ biopharma pros reading Endpoints daily — and it’s free.

One of Pfizer’s new vaccine TV commercials never mentions its vaccine brand Comirnaty. In fact, it doesn’t mention vaccines or Covid-19 at all and doesn’t show people wearing masks or social distancing. Yet it’s clear the ad is talking about the pharma’s Covid-19 vaccines.

The ad’s voiceover talks about the unremarkable moments and routines that matter, like getting a coffee refill at a diner or Sunday grocery shopping. The images shift from those everyday moments to a scientists and purple lidded glass vials spinning off a production line and being packed into freezers.

Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.

Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.

Sen. Joe Manchin (D-WV) at the Capitol on Friday, Dec. 17 (J. Scott Applewhite/AP Images)

Sen. Joe Manchin on Sunday derailed President Biden’s trillion-dollar spending package, effectively halting the Democrats’ best chance yet to allow Medicare to negotiate drug prices, among a bevy of other health-related provisions tacked onto the Build Back Better Act.

White House press secretary Jen Psaki, stunned by Manchin’s announcement on Fox News, said in a statement: ‘Senator Manchin claims that this change of position is related to inflation, but the think tank he often cites on Build Back Better — the Penn Wharton Budget Institute — issued a report less than 48 hours ago that noted the Build Back Better Act will have virtually no impact on inflation in the short term, and, in the long run, the policies it includes will ease inflationary pressures.’

Brian Culley, Lineage Cell Therapeutics CEO

In a lucrative market for ocular degeneration, Roche has long sat on a gold mine with its drug Lucentis — but the times are changing. Now, Roche will bet on a regenerative approach to eye disease with a small biotech with some very early but promising data.

Genentech will pay $50 million upfront and a potential $620 million in downstream milestones for licensing rights to Lineage Cell Therapeutics’ OpRegen program, a cell therapy that aims to regenerate healthy versions of retinal pigment epithelial cells in patients’ eyes, the companies said Monday.

Unlock this story instantly and join 126,100+ biopharma pros reading Endpoints daily — and it’s free.

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

Moderna has backed down on its patent fight with the NIH, calling a truce by dropping its patent application for now.

Following a heated feud regarding who invented its lifesaving Covid-19 vaccine that was increasingly spilling into public view, the biotech said it ‘has decided at this time not to pursue’ a patent issuance for the mRNA sequence of its jab. But Moderna also filed a continuation application so that some of the claims may still be issued later.

Unlock this story instantly and join 126,100+ biopharma pros reading Endpoints daily — and it’s free.

As the new year rapidly approaches, and gyms and health food stores across America prepare for a wave of people seeking weight loss, Novo Nordisk has announced that it does not expect to meet demand for Wegovy, its prescription injectable weight-loss medication for obesity, until the second half of 2022 in the US.

The shortage comes due to manufacturing issues at a contract manufacturer that was tasked with filling syringes for the pens. The news comes just days after Novo announced that it would invest roughly $2.58 billion to expand its manufacturing hub in Kalundborg, Denmark with three new facilities and the expansion of a fourth to keep up with the success of its diabetes and obesity med semaglutide, Wegovy and Rybelsus.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

With a jam-packed pipeline to parse, Novartis chief Vas Narasimhan has helped investors out in the past by highlighting a few key programs his team thinks could be easy winners. One of those drugs has now hit the skids in two late-stage tests, losing some of its luster as a potential centerpiece medicine moving ahead.

Novartis’ ligelizumab, a ‘high-affinity’ anti-immunoglobulin E antibody failed to beat out standard-of-care Xolair — its own partnered drug with Genentech — in two Phase III studies in patients with the skin disease chronic spontaneous urticaria, the company said Monday.
https://endpts.com/fda-hands-astrazeneca-amgen-broad-approval-for-asthma-antibody-clearing-blockbuster-path/