FDA re­vis­es ac­tion on com­pound­ed ibupro­fen, cit­ing oral ver­sion short­age

The FDA put out guid­ance Thurs­day ex­pand­ing sup­ply of a spe­cif­ic form of ibupro­fen, one of the ma­jor ac­tive in­gre­di­ents in over-the-counter pain re­lief med­i­cine such as Advil.

In its newest re­vised guid­ance, the fed­er­al reg­u­la­to­ry agency is now giv­ing the green light to out­sourc­ing fa­cil­i­ties to pro­vide com­pound­ed, oral­ly sus­pend­ed forms of ibupro­fen to state-li­censed phar­ma­cies that can be giv­en to pa­tients at home, pro­vid­ed that a pa­tient has a valid and pa­tient-spe­cif­ic pre­scrip­tion.

Pre­vi­ous guid­ance came out back in Jan­u­ary, ini­tial­ly al­low­ing out­sourc­ing fa­cil­i­ties to com­pound oral­ly sus­pend­ed ibupro­fen that would be used in hos­pi­tals and health sys­tems amid “record high de­mand,” FDA said at the time.

FDA cit­ed re­ports of hos­pi­tals and phar­ma­cies hav­ing dif­fi­cul­ty se­cur­ing oral sus­pen­sion forms of ibupro­fen for kids and adults un­able to swal­low sol­id forms of the pain re­lief drug. The agency added that the in­crease in de­mand is tied to a surge in cas­es from three virus­es: Covid-19, RSV and in­fluen­za — all of which can spark fevers in chil­dren.

“We rec­og­nize that hos­pi­tals, health sys­tems, State-li­censed phar­ma­cies, and ap­plic­a­ble Fed­er­al fa­cil­i­ties have con­cerns about as­sur­ing ac­cess to these drug prod­ucts to use for fever and pain treat­ment of pe­di­atric pa­tients, and adults who are un­able to swal­low sol­id oral dosage form prod­ucts, dur­ing the win­ter months when res­pi­ra­to­ry ill­ness­es are like­ly to be el­e­vat­ed. There­fore, FDA is is­su­ing this pol­i­cy to pro­vide tem­po­rary flex­i­bil­i­ty,” the reg­u­la­to­ry agency wrote.

Com­pound­ing mat­ters is when a physi­cian, phar­ma­cist, or in this case an out­sourc­ing fa­cil­i­ty, com­bines or al­ters in­gre­di­ents of ap­proved drugs to one more tai­lored to spe­cif­ic needs of a pa­tient — which may not be FDA ap­proved.

FDA said in its guid­ance that out­sourc­ing fa­cil­i­ties should meet cer­tain stan­dards when it comes to man­u­fac­tur­ing the com­pound­ed ver­sion of ibupro­fen, such as meet­ing mono­graph stan­dards, com­ply­ing with the FD&C Act, test­ing for di­eth­yl­ene gly­col and eth­yl­ene gly­col con­t­a­m­i­na­tion on any com­po­nent deemed high­er-risk for con­t­a­m­i­na­tion, and more.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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Keytru­da be­fore and af­ter lung can­cer surgery cuts re­lapse risk by 42%, but doesn’t im­prove sur­vival: #AS­CO23

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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