FDA green­lights sec­ond Ebo­la treat­ment in three months, hand­ing new OK to Ridge­back­'s Eban­ga

A hus­band-and-wife biotech that li­censed a Covid-19 an­tivi­ral be­fore quick­ly part­ner­ing on it with Mer­ck ear­li­er this sum­mer has a new ap­proval in an­oth­er high­ly in­fec­tious dis­ease — Ebo­la.

Wendy Hol­man

Ridge­back Bio­ther­a­peu­tics, co-found­ed by CEO Wendy Hol­man and her hus­band Wayne Hol­man, a hedge fund man­ag­er who used to work for a com­pa­ny in­volved in one of the biggest in­sid­er trad­ing scan­dals in his­to­ry, has clinched an FDA OK for an­su­vimab-zykl to treat the dead­ly Ebo­la virus in adults and chil­dren. The drug, a mon­o­clon­al an­ti­body, will be mar­ket­ed as Eban­ga.

It’s the sec­ond-ever Ebo­la treat­ment to gain US ap­proval, both of which came over the last three months. Re­gen­eron’s an­ti­body cock­tail In­mazeb marked the first back in Oc­to­ber and was cho­sen by BAR­DA for the na­tion­al stock­pile in case of an out­break.

Both treat­ments were part of an NIH-spon­sored study in the De­mo­c­ra­t­ic Re­pub­lic of the Con­go dur­ing the coun­try’s 2018-19 out­break. Launched in Nov 2018, the study looked at four dif­fer­ent Ebo­la ther­a­pies and was stopped less than a year lat­er due to the over­whelm­ing­ly pos­i­tive re­sults pro­duced by Re­gen­eron and Ridge­back’s drugs.

The study it­self was ran­dom­ized and open-la­bel, with 174 pa­tients in the Eban­ga arm and 168 in the con­trol arm. Re­searchers honed in on 28-day mor­tal­i­ty rates as the pri­ma­ry end­point and found that, of those who re­ceived Eban­ga, 35.1% died af­ter 28 days. That fig­ure com­pared to 49.4% of those tak­ing the con­trol.

Reg­u­la­tors ad­vised against tak­ing both Eban­ga and an Ebo­la vac­cine at the same time. They not­ed that most of the com­mon side ef­fects from Eban­ga can al­so be con­fused with Ebo­la symp­toms them­selves, and rec­om­mend­ed dis­con­tin­u­a­tion should pa­tients de­vel­op a hy­per­sen­si­tiv­i­ty re­ac­tion.

Al­so in the study were a ZMapp an­ti­body and Gilead’s an­tivi­ral remde­sivir, which has since been re­pur­posed for Covid-19 and en­dorsed with a full FDA ap­proval de­spite lin­ger­ing ques­tions.

It’s been an event­ful year for the Mi­a­mi-based biotech. At the out­set of the Covid-19 pan­dem­ic in March, Hol­man struck a deal with Emory Uni­ver­si­ty to li­cense an ex­per­i­men­tal coro­n­avirus pill in­vent­ed by re­searchers there with $16 mil­lion in gov­ern­ment grants. Two months lat­er, Mer­ck gained world­wide rights to the pro­gram, dubbed EI­DD-2801, from Ridge­back for an undis­closed sum as part of their col­lab­o­ra­tion.

The quick turn­around drew con­cerns that Ridge­back at­tempt­ed to cash in big on a tax­pay­er-fund­ed pro­gram, with promi­nent Har­vard bioethi­cist Aaron Kessel­heim blast­ing the move in the Wash­ing­ton Post at the time. But in a Na­ture study pub­lished ear­li­er this month, re­sults showed that EI­DD-2801 com­plete­ly sup­pressed SARS-CoV-2 trans­mis­sion with­in 24 hours in fer­rets.

For Eban­ga, it’s not im­me­di­ate­ly clear where and how the drug will be used, giv­en Re­gen­eron’s pres­ence in the US strate­gic stock­pile and the DRC.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Todd Zavodnick, Dermavant CEO

With top­i­cal ap­proval, Der­ma­vant looks to bring new stan­dard-of-care to plaque pso­ri­a­sis pa­tients

Dermavant CEO Todd Zavodnick has been plotting to upend the plaque psoriasis market for years now. And with the company’s first approval on Tuesday, he’s pulling the trigger.

The FDA on Tuesday approved Dermavant’s “cosmetically elegant” vanishing cream tapinarof, the first steroid-free topical medication in its class, now marketed as Vtama. And unlike other launches, which could take months, Zavodnick is ready to roll it out as early as next week.

Raymond Tesi, INmune Bio CEO

Man­u­fac­tur­ing con­cerns spur clin­i­cal hold on small biotech's Alzheimer's tri­al — shares plunge

The FDA is keeping an experimental Alzheimer’s therapy out of the US for now, placing a clinical hold on INmune Bio’s IND for a Phase II trial until it can provide additional information on chemistry, manufacturing and controls.

INmune Bio, which gets its name from the approach of leveraging the innate immune system to fight disease, said it was informed about the hold via email and expects more details in a later letter. In a brief statement, it said the agency was looking for more information about CMC “of the newly manufactured XPro1595.”

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