Sanofi's con­tro­ver­sial dengue vac­cine wins FDA ap­proval, with a raft of caveats

Sanofi’s con­tro­ver­sial dengue vac­cine, which took two decades to de­vel­op, has made it across the FDA fin­ish line — but it wasn’t pret­ty. Less than a month af­ter a pan­el of ex­perts de­liv­ered mixed re­views for the shot, on Wednes­day, the US health reg­u­la­tor sanc­tioned the use of Deng­vax­ia as the first-ever prod­uct to pre­vent the mos­qui­to-borne dis­ease in cer­tain in­di­vid­u­als who have pre­vi­ous­ly con­tract­ed dengue and who live in ar­eas rife with the dis­ease.

The FDA has lim­it­ed the use of the vac­cine in in­di­vid­u­als aged 9 to 16 who have lab­o­ra­to­ry-con­firmed pre­vi­ous dengue in­fec­tion and live in ar­eas where the dis­ease is en­dem­ic, such as Puer­to Ri­co, the US Vir­gin Is­lands and Amer­i­can Samoa. Orig­i­nal­ly, Sanofi $SNY had sought to se­cure ap­proval for peo­ple aged 9 through 45, but the FDA ad­vi­so­ry pan­el last month foiled that bid, on­ly agree­ing to rec­om­mend its use in chil­dren.

Deng­vax­ia — which is ad­min­is­tered as three sep­a­rate in­jec­tions — was found to be rough­ly 76% ef­fec­tive in pre­vent­ing symp­to­matic dengue dis­ease in in­di­vid­u­als 9 through 16 years of age who pre­vi­ous­ly had lab­o­ra­to­ry-con­firmed dengue dis­ease, the FDA not­ed. But in the Unit­ed States and its ter­ri­to­ries, no avail­able tests have been cleared by the FDA to de­ter­mine a pre­vi­ous dengue in­fec­tion, Sanofi said.

The French drug­mak­er once had block­buster dreams for the world’s first dengue vac­cine, but that hope was mas­sa­cred af­ter it was forced to con­cede in late 2017 that Deng­vax­ia could en­hance the risk of se­vere dengue in chil­dren who had nev­er been ex­posed to the virus — on­ly af­ter the Philip­pines used $70 mil­lion worth of the shot in a mass vac­ci­na­tion cam­paign for 800,000 chil­dren.

But even be­fore the Philip­pines’ pub­lic health cri­sis, ex­perts had warned that vac­ci­na­tion with Deng­vax­ia in those who had not al­ready been in­fect­ed by one of the four dif­fer­ent serotypes of the virus faced a po­ten­tial­ly life-threat­en­ing fever up­on a sub­se­quent in­fec­tion. This is be­cause their bod­ies would like­ly treat the first re­al dengue in­fec­tion as their sec­ond, thanks to the vac­cine. Ac­cord­ing to the FDA, rough­ly 95% of all se­vere/hos­pi­tal­ized cas­es of dengue are as­so­ci­at­ed with sec­ond dengue virus in­fec­tion.

In March, Philip­pine of­fi­cials said they were prepar­ing crim­i­nal charges against Sanofi, in con­nec­tion with 10 deaths they said were linked to the vac­cine. Sanofi op­posed their find­ings.

The virus is wide­spread across the trop­ics. Se­vere dengue was first rec­og­nized in the 1950s dur­ing dengue epi­demics in the Philip­pines and Thai­land, cur­rent­ly af­fects most Asian and Latin Amer­i­can coun­tries, and is con­sid­ered a lead­ing cause of hos­pi­tal­iza­tion and death among chil­dren and adults in these re­gions, ac­cord­ing to the WHO. The CDC es­ti­mates that each year, about 400 mil­lion dengue virus in­fec­tions oc­cur glob­al­ly. The dengue virus is car­ried by fe­male Aedes ae­gyp­ti mos­qui­toes (and to a less­er ex­tent, Ae. al­bopic­tus)the same species that al­so trans­mits chikun­gun­ya, yel­low fever and Zi­ka.

The French drug­mak­er has earned a trop­i­cal dis­ease pri­or­i­ty re­view vouch­er — grant­ed to drug­mak­ers to re­ward drug/vac­cine de­vel­op­ment for trop­i­cal dis­eases that typ­i­cal­ly don’t get much at­ten­tion — in con­nec­tion with the ap­proval. Some of these vouch­ers have been pre­vi­ous­ly sold for hun­dreds of mil­lions of dol­lars.

Deng­vax­ia has al­ready been cleared for use in 19 coun­tries, and last year was ap­proved by the Eu­ro­pean Union for in­di­vid­u­als aged 9 to 45 years who have been in­fect­ed with dengue virus be­fore and who live in ar­eas where the in­fec­tion is en­dem­ic.

Japan’s Take­da has a ri­val dengue vac­cine in late-stage de­vel­op­ment.

George Yancopoulos (Regeneron)

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In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

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Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

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Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

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Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

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Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

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The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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