Af­ter NIH tri­al, EMA be­gins rolling re­view for remde­sivir, set­ting up po­ten­tial au­tho­riza­tions in US and Eu­rope

A day af­ter the NIH re­leased pos­i­tive re­sults from their tri­al test­ing remde­sivir in Covid-19, the EMA has an­nounced the start of a rolling re­view process for the drug. With an FDA de­ci­sion ex­pect­ed to ar­rive in the com­ing days, the news sets the stage for the Gilead an­tivi­ral to be­come the stan­dard-of-care for the dead­ly virus in both the US and Eu­rope.

Yes­ter­day morn­ing, Gilead is­sued a press re­lease that the NIH would soon is­sue pos­i­tive da­ta on a much-an­tic­i­pat­ed tri­al test­ing their an­tivi­ral remde­sivir against a place­bo in Covid-19 pa­tients. The news prompt­ed im­me­di­ate spec­u­la­tion of whether an emer­gency use au­tho­riza­tion (EUA) — a clear­ance from the FDA that by­pass­es the lengthy ap­proval process — would fol­low. The agency had con­tro­ver­sial­ly is­sued an EUA for the an­ti­malar­i­als hy­drox­y­chloro­quine and chloro­quine in March, a de­ci­sion that was tak­en with­out the sup­port of a ran­dom­ized con­trolled tri­al.

“Remde­sivir would ap­pear to meet or ex­ceed stan­dard for au­tho­riza­tion un­der EUA, es­pe­cial­ly rel­a­tive to oth­er EUAs is­sued,” for­mer FDA chief Scott Got­tlieb said on Twit­ter an hour af­ter Gilead’s press re­lease.

Af­ter the da­ta came out — show­ing a 31% im­prove­ment in re­cov­ery time and a nu­mer­i­cal, but not sta­tis­ti­cal­ly sig­nif­i­cant, im­prove­ment in mor­tal­i­ty for pa­tients tak­ing the drug — The New York Times re­port­ed that the FDA could au­tho­rize the drug that day. In a state­ment to End­points News, the FDA didn’t com­ment on the re­port but said the agency has “been en­gaged in sus­tained and on­go­ing dis­cus­sions with Gilead Sci­ences re­gard­ing mak­ing remde­sivir avail­able to pa­tients as quick­ly as pos­si­ble, as ap­pro­pri­ate.”

An­tho­ny Fau­ci, di­rec­tor of the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, in an Oval Of­fice press con­fer­ence, said that the drug should be­come the “new stan­dard of care” for all Covid-19 clin­i­cal tri­als.

The EMA, how­ev­er, has tak­en a hard­er stance on emer­gency au­tho­riza­tions for Covid-19. Four days af­ter the FDA is­sued its let­ter al­low­ing the use of an­ti­malar­i­als, the EMA is­sued a con­trast­ing state­ment. They cau­tioned physi­cians against pre­scrib­ing the drug out­side their ap­proved use or spe­cif­ic na­tion­al pro­to­cols, cit­ing both po­ten­tial side ef­fects and not­ing that, “ef­fi­ca­cy in treat­ing COVID-19 is yet to be shown in stud­ies. (Sub­se­quent da­ta on the drug have yet to clear the pic­ture, al­though large ran­dom­ized con­trol stud­ies are un­der­way.)

The agency said they be­gan the rolling re­view process for remde­sivir in re­sponse to the da­ta from the NIH tri­al, which was the largest ran­dom­ized, place­bo-con­trolled study to read­out on a po­ten­tial Covid-19 drug and the first to show ef­fi­ca­cy. They said they will al­so con­sid­er oth­er da­ta around the drug, in­clud­ing a Chi­nese study pub­lished in The Lancet yes­ter­day that showed no sig­nif­i­cant ef­fi­ca­cy for the drug but in a far small­er pa­tient pop­u­la­tion.

The agency said they could not of­fer a time­line for when a de­ci­sion would be made, al­though the process would be faster than the stan­dard ap­proval process for new drugs.

An emer­gency use au­tho­riza­tion would po­ten­tial­ly al­low for more pa­tients to ac­cess the drug. To date, the an­tivi­ral, orig­i­nal­ly de­vel­oped for he­pati­tis C,  has on­ly been avail­able to pa­tients in clin­i­cal tri­als or un­der spe­cif­ic com­pas­sion­ate use or ex­pand­ed ac­cess pro­to­cols.

In an open let­ter yes­ter­day, Gilead CEO Daniel O’Day said the com­pa­ny has been ramp­ing up sup­ply of the drug since Jan­u­ary and now have about 1.5 mil­lion dos­es on hand. That would be enough for 140,000 cours­es of 10-day treat­ment or 280,000 cours­es of 5-day treat­ments — a Gilead study al­so re­leased yes­ter­day sug­gest­ed both of­fered sim­i­lar ef­fi­ca­cy.

“On the sup­ply side, we are work­ing to build a glob­al con­sor­tium of phar­ma­ceu­ti­cal and chem­i­cal man­u­fac­tur­ers to ex­pand glob­al ca­pac­i­ty and pro­duc­tion,” he said. “In the event of reg­u­la­to­ry ac­tion, we are in dis­cus­sions with var­i­ous groups about how we might bring remde­sivir to the de­vel­op­ing world.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

So­cial im­age: An­tho­ny Fau­ci and Deb­o­rah Birx, AP Im­ages

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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