Not just the ap­proved in­di­ca­tions: FDA to study DTC drug ads that in­clude sec­ondary end­point da­ta

While most of the world bans di­rect-to-con­sumer ad­ver­tis­ing for pre­scrip­tion drugs, the FDA said Fri­day that it’s launch­ing a study in­to how peo­ple might per­ceive such ads that in­clude in­for­ma­tion on sec­ondary end­points that are not part of an ap­proved in­di­ca­tion.

The on­line re­search will ex­am­ine the im­pact of adding a dis­clo­sure about a sec­ondary claim (i.e. clin­i­cal ben­e­fit in­for­ma­tion based on a sec­ondary end­point re­port­ed in a prod­uct’s ap­proved la­bel­ing) in DTC and health­care provider-di­rect­ed on­line pro­mo­tions.

“In some cas­es, truth­ful and non-mis­lead­ing pre­sen­ta­tions about sec­ondary end­points in well-de­signed clin­i­cal stud­ies can pro­vide re­li­able in­for­ma­tion about treat­ment ef­fects that may be dis­tinct from the treat­ment ef­fects de­scribed in the prod­uct’s in­di­ca­tion state­ment,” FDA said in the Fed­er­al Reg­is­ter ex­plain­ing the need for the re­search.

The agency of­fered the ex­am­ple of a can­cer drug in­di­cat­ed to treat a spe­cif­ic type of can­cer based on a pri­ma­ry end­point of sur­vival, where­as a sec­ondary end­point in the study may pro­vide da­ta about an ad­di­tion­al dis­tinct ben­e­fit, such as func­tion­al sta­tus.

For this re­search, the agency is fo­cus­ing on di­a­betes drugs and the sec­ondary claim dis­clo­sure that ex­plains “even though the drug is not in­di­cat­ed for weight loss, that it can help some peo­ple lose weight.”

One com­menter on the re­search said it “lacks prac­ti­cal util­i­ty” be­cause it treats the sec­ondary ben­e­fit claim as not re­lat­ed to the prod­uct’s in­di­cat­ed us­es.

But FDA said it’s not mak­ing any gen­er­al­iza­tions about the ap­proval sta­tus of the sec­ondary claim, adding, “In this sce­nario, a dis­clo­sure about the sec­ondary claim may help the au­di­ence in­ter­pret the sec­ondary claim and pro­vide con­text. The pur­pose of this study is to eval­u­ate such dis­clo­sures about this spe­cif­ic type of sec­ondary claim and mea­sure the im­pact on per­cep­tions of and at­ti­tudes to­ward the prod­uct.”

In re­sponse to an­oth­er ques­tion on whether it’s ap­pro­pri­ate for the FDA to study the prac­tice of med­i­cine, the agency de­fend­ed the need for this re­search, claim­ing, “It is a prop­er sub­ject for FDA re­search to study whether par­tic­u­lar fram­ing of state­ments con­tributes to an HCP’s ac­cu­rate un­der­stand­ing or to mis­un­der­stand­ing about drugs to in­form their pre­scrib­ing de­ci­sions in the course of their prac­tice of med­i­cine.”

In ad­di­tion to the sec­ondary claims re­search, the agency al­so said it’s work­ing on an­oth­er study re­lat­ed to the dis­clo­sure that a cer­tain prod­uct is a biosim­i­lar.

FDA said the pur­pose of that study is “to un­der­stand whether par­tic­i­pants would ask their doc­tor to switch their med­ica­tion af­ter view­ing the ad.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

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