Lil­ly's Taltz wins third ap­proval, this time in pa­tients with ac­tive anky­los­ing spondyli­tis

Lil­ly’s mon­o­clon­al an­ti­body, Taltz, which is al­ready ap­proved for pso­ri­at­ic arthri­tis and plaque pso­ri­a­sis has won its third ap­proval. The FDA has cleared its use in ac­tive anky­los­ing spondyli­tis (AS), a chron­ic in­flam­ma­to­ry rheumat­ic dis­or­der that af­fects the pelvic joints and spine, and can be char­ac­ter­ized by in­flam­ma­to­ry back pain, stiff­ness and im­paired func­tion and mo­bil­i­ty.

Taltz — akin to No­var­tis’ $NVS block­buster Cosen­tyx — in­hibits IL-17A, a cy­tokine in­volved in in­flam­ma­to­ry and im­mune re­spons­es. The drug, which will now al­so ad­dress the rough­ly 1.6 mil­lion Amer­i­cans with AS, gen­er­at­ed about $354 mil­lion in the sec­ond quar­ter.

Taltz was test­ed in two place­bo-con­trolled Phase III stud­ies that en­com­passed 657 AS pa­tients to eval­u­ate the pro­por­tion of pa­tients the drug had an im­pact on, in terms of symp­toms of pain, in­flam­ma­tion and func­tion at 16 weeks. In the COAST-V tri­al, which in­clud­ed pa­tients who had nev­er been treat­ed with an an­tirheumat­ic bi­o­log­ic, 48% of Taltz-treat­ed pa­tients achieved the re­sponse every four weeks ver­sus 18% of place­bo-treat­ed pa­tients (p<0.0001). In COAST-W tri­al, which in­volved pa­tients who did not ad­e­quate­ly ben­e­fit or were in­tol­er­ant to tu­mor necro­sis fac­tor (TNF) in­hibitors, 25% of pa­tients treat­ed with Taltz every four weeks achieved a re­sponse, ver­sus 13% of pa­tients giv­en the place­bo (p<0.05).

Four months ago, Lil­ly’s $LLY Taltz al­so cleared a late-stage study called COAST-X, in pa­tients with a form of in­flam­ma­to­ry arthri­tis in which there is no vis­i­ble ev­i­dence of dam­age on X-rays — non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis (nr-AxS­pA).

Cosen­tyx is al­so ap­proved for AS, as is UCB’s TNF block­er Cimzia.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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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.

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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.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

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.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.

Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

Go­ing block­buster hunt­ing, Vas Narasimhan out­lines vi­sion for ‘pure-play’ No­var­tis

By the time 2023 is over, Novartis expects to be moving much lighter: It will have spun out its generics subsidiary Sandoz, completed layoffs of thousands of staffers worldwide and put in new internal structures for running the company.

And it will be ready to hunt for blockbusters.

CEO Vas Narasimhan underscored Novartis’ upcoming transformation into a “pure-play” company, reiterating across a series of calls — one with reporters, two with investors and analysts — that the new structure would boost its R&D productivity and sharpen its focus on big, new medicines.

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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.”

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