In key win, Ab­b­Vie lands FDA ap­proval for Al­ler­gan's blurred-vi­sion eye drop

Ab­b­Vie’s age-re­lat­ed blur­ry vi­sion drug for ag­ing adults was giv­en the OK by the FDA Fri­day, mak­ing it the first eye drop to treat an eye con­di­tion that af­fects 128 mil­lion Amer­i­cans.

For­mer­ly AGN-190584, the drug has proven a bright spot in Al­ler­gan’s pipeline since Ab­b­Vie bought it out for $63 bil­lion, which has seen more set­backs than wins.

The dai­ly pre­scrip­tion eye drop is ap­proved to treat pres­by­opia. Vuity is a for­mu­la­tion of pi­lo­carpine, a well-known drug for in­traoc­u­lar pres­sure and var­i­ous types of glau­co­ma, among oth­er us­es. Al­ler­gan had de­ployed a dif­fer­ent de­liv­ery method that promised to make the drug bet­ter tol­er­at­ed.

Michael Sev­eri­no

“We are proud to of­fer Vuity as a first-of-its-kind once-dai­ly eye drop that we be­lieve will change the way peo­ple and their eye doc­tors ap­proach pres­by­opia. The FDA ap­proval of Vuity ex­em­pli­fies our con­tin­ued pur­suit of in­no­v­a­tive new treat­ments that push the bound­aries of what’s pos­si­ble in eye care,” said Michael Sev­eri­no, pres­i­dent of Ab­b­Vie.

The ap­proval means that the tar­get­ed time­line has been met, as Ab­b­Vie aimed for an ap­proval be­fore New Year’s. In Ju­ly, the com­pa­ny of­fered a close-up of its da­ta. The Phase III study dubbed Gem­i­ni I of­fered proof that the eye­drops de­liv­er fast though tran­sient im­prove­ments in read­ing abil­i­ty, with a sta­tis­ti­cal­ly sig­nif­i­cant group of pa­tients adding three lines or more when view­ing a read­ing chart.

More da­ta showed that 75% of par­tic­i­pants achieved at least a two-line im­prove­ment, and 90% of par­tic­i­pants achieved 20/40 vi­sion. Of­ten, adults cope with blurred vi­sion that comes along with ag­ing by us­ing read­ing glass­es or in­creas­ing font size on screens and the light­ing in rooms. Vuity is seen as an al­ter­na­tive to those and sur­gi­cal op­tions.

The pro­gram was orig­i­nal­ly part of Al­ler­gan’s pipeline un­til it was ac­quired by Ab­b­vie in a $63 bil­lion buy­out. That deal was large­ly cen­tered around the $16 bil­lion Botox fran­chise, and the com­pa­ny has slow­ly end­ed oth­er R&D projects over time.

In two Phase III stud­ies, Gem­i­ni 1 and Gem­i­ni 2, 750 par­tic­i­pants be­tween the ages of 40 and 65 were in­struct­ed to ad­min­is­ter one drop of Vuity or a place­bo in­to their eyes once a day. No se­ri­ous side ef­fects were re­port­ed.

“As we age, the lens­es of our eyes be­come less flex­i­ble, mak­ing it more dif­fi­cult to fo­cus on things up close. VUITY of­fers a nov­el, safe, well-tol­er­at­ed and ef­fec­tive al­ter­na­tive to cur­rent op­tions for man­ag­ing age-re­lat­ed blur­ry near vi­sion,” George War­ing IV, the med­ical di­rec­tor at the War­ing Vi­sion In­sti­tute and prin­ci­pal study in­ves­ti­ga­tor, said in a press re­lease. “I am par­tic­u­lar­ly en­cour­aged by the rapid on­set of ac­tion and du­ra­tion of ef­fi­ca­cy for VUITY to im­prove near and in­ter­me­di­ate vi­sion with­out im­pact­ing dis­tance vi­sion with one drop dai­ly, par­tic­u­lar­ly for those with mild to mod­er­ate pres­by­opia.”

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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UP­DAT­ED: FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.