GSK looks to stand out in the se­vere asth­ma space with at-home in­jec­tions for kids 6 to 11 years old

Glax­o­SmithK­line’s block­buster Nu­cala may have been the first IL-5 drug to win mar­ket­ing ap­proval in se­vere asth­ma back in 2015, but new­er ri­vals like As­traZeneca’s Fasen­ra have turned up the heat in re­cent years. Now GSK’s hop­ing an eas­i­er route of ad­min­is­tra­tion for kids will help set it apart from the pack.

The FDA on Mon­day ap­proved a 40 mg pre­filled sy­ringe of Nu­cala for cer­tain kids be­tween 6 and 11 years old, mean­ing they can take the drug at home in­stead of trekking to the doc­tor’s of­fice every four weeks. That makes a big dif­fer­ence for chil­dren with se­vere eosinophilic asth­ma (SEA), who may have trou­ble fit­ting in ap­point­ments around school and care­givers’ jobs, GSK’s US se­nior med­ical lead Tom Cor­bridge told End­points News.

Tom Cor­bridge

“The abil­i­ty to be much more flex­i­ble and al­low for at-home ad­min­is­tra­tion through the pre­filled sy­ringe re­al­ly is a ter­rif­ic step for­ward, in my view, to help with less dis­rup­tion in the life of an asth­mat­ic child and their fam­i­ly,” Cor­bridge said. “It gives the op­por­tu­ni­ty to choose.”

Nu­cala was ap­proved as an add-on main­te­nance ther­a­py for kids and adults 12 years and old­er with SEA back in 2015, and GSK has been pro­vid­ing at-home ad­min­is­tra­tion op­tions for these pa­tients since 2019. The drug was al­so cleared that year for 6- to 11-year-olds, but those pa­tients had to re­ceive their in­jec­tions by a physi­cian un­til now.

SEA is caused by high lev­els of white blood cells called eosinophils. Nu­cala is be­lieved to work by pre­vent­ing IL-5 from bind­ing to its re­cep­tor on the sur­face of eosinophils, di­min­ish­ing blood eosinophils, but not erad­i­cat­ing them al­to­geth­er, ac­cord­ing to GSK (though Cor­bridge not­ed that the mech­a­nism of ac­tion still hasn’t been ful­ly elu­ci­dat­ed). About 6 mil­lion chil­dren in the US have asth­ma, but on­ly 2.5% to 5% of cas­es are char­ac­ter­ized as se­vere. Nu­cala raked in $1.34 bil­lion in 2020, snap­ping up an ap­proval in hy­per­e­osinophilic syn­drome (HES) that year, and an­oth­er in chron­ic rhi­nos­i­nusi­tis with nasal polyps (CR­SwNP) in 2021.

But oth­ers — like As­traZeneca’s Fasen­ra and Te­va’s Cinqair — are clos­ing in. Fasen­ra net­ted $949 mil­lion in 2020 sales, and in Sep­tem­ber of that year As­traZeneca un­veiled a pos­i­tive batch of Phase III da­ta in CR­SwNP. While Nu­cala is ad­min­is­tered every four weeks, pa­tients on Fasen­ra re­ceive 30 mg dos­es every four weeks for the first three dos­es, and once every eight weeks af­ter that.

In 2018 — days af­ter re­ceiv­ing a com­plete re­sponse let­ter in COPD — GSK re­leased da­ta pulled from 11 dif­fer­ent stud­ies sug­gest­ing that Nu­cala “sig­nif­i­cant­ly re­duced clin­i­cal­ly sig­nif­i­cant ex­ac­er­ba­tions and im­proved asth­ma con­trol” com­pared to Fasen­ra and Cinqair, the oth­er two an­ti-IL-5s in the se­vere asth­ma are­na. Nu­cala is still the on­ly an­ti-IL-5 ap­proved for the 6 to 11 age group — but as of Oc­to­ber, there’s al­so Sanofi and Re­gen­eron’s Dupix­ent, which tar­gets IL-4 and IL-13 and can be ad­min­is­tered at home.

Reg­u­la­tors gave Dupix­ent a nod based on piv­otal da­ta that showed the drug re­duced the rate of se­vere asth­ma at­tacks in kids 6 to 11 years old by an av­er­age of 65% over one year com­pared to place­bo.

When asked what dif­fer­en­ti­ates Nu­cala from com­peti­tors, Cor­bridge said it’s the breadth of avail­able da­ta.

“When you look at Nu­cala, mepolizum­ab, there’s an ex­ten­sive da­ta set that is avail­able, not on­ly clin­i­cal tri­als, con­trolled tri­als in pa­tients, but al­so a num­ber of open-la­bel stud­ies and re­al-world stud­ies that ex­tend in­to not on­ly asth­ma, most­ly in adults, but al­so in oth­er eosinophilic dri­ven dis­eases,” he said. “I would say that is cer­tain­ly some­thing we’re very proud of.”

So who’s el­i­gi­ble for the at-home pre-filled sy­ringes? Cor­bridge says it’s a shared de­ci­sion be­tween physi­cians and care­givers. Pa­tients who wish to re­ceive their in­jec­tions in per­son will still be able to do so. Since it was made avail­able in 2019, Cor­bridge says a grow­ing num­ber of pa­tients are opt­ing for at-home ver­sions of Nu­cala.

“That’s par­tic­u­lar­ly im­por­tant of course now in the era of Covid where, you know, at-home ad­min­is­tra­tion may al­so be prefer­able by pa­tients, their fam­i­lies and even care­givers,” he said.

GSK’s al­so test­ing a long-act­ing IL-5 treat­ment dubbed GSK’294 for pa­tients with SEA, which could po­ten­tial­ly be ad­min­is­tered once every six months. The phar­ma gi­ant dosed the first pa­tient in a Phase III study back in March, and is still await­ing the re­sults.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.