FDA ex­e­cutes a 180 on Ther­a­peu­tic­sMD ther­a­py, hand­ing it an OK — and stok­ing con­cerns about po­lit­i­cal in­flu­ence

A year af­ter the FDA hand­ed Ther­a­peu­tic­sMD $TXMD a re­jec­tion let­ter for its ther­a­py pre­vent­ing vagi­nal pain dur­ing sex, the agency has done a com­plete 180 — ap­prov­ing the treat­ment af­ter wav­ing off the safe­ty con­cerns that had once war­rant­ed a CRL.

The de­ci­sion to drop the CRL and al­low the ap­pli­ca­tion to pro­ceed with­out meet­ing spec­i­fied hur­dles is one of three the FDA ex­e­cut­ed in the weeks af­ter Scott Got­tlieb jumped in­to the top job at the FDA, rais­ing con­cerns that po­lit­i­cal in­flu­ence was chang­ing the for­tunes of some of the com­pa­nies with busi­ness be­fore the agency. In this case, Got­tlieb — hand­ed a man­date to speed ap­provals — won the nom­i­na­tion the day af­ter the re­jec­tion was an­nounced by Ther­a­peu­tic­sMD.

Scott Got­tlieb

Two oth­er com­pa­nies al­so earned a re­prieve un­der Got­tlieb: Am­i­cus, where CEO John Crow­ley had lob­bied of­fi­cials claim­ing that their re­jec­tion of its ex­per­i­men­tal Fab­ry drug mi­gala­s­tat would de­lay it by 5 to 7 years, far more than the 2 years he told share­hold­ers; and Eli Lil­ly, which re­cent­ly won over an ex­pert pan­el on a ques­tion­able low dose of baric­i­tinib. 

In Am­i­cus’ case, the FDA put the drug on the agency’s in­side track, of­fer­ing a fast pri­or­i­ty re­view ahead of an ex­pect­ed ap­proval.

In this case, Ther­a­peu­tic­sMD — which is chaired by ex-HHS sec­re­tary Tom­my Thomp­son, who ran a group of promi­nent Bush ad­min­is­tra­tion Re­pub­li­cans back­ing Don­ald Trump for pres­i­dent — told in­vestors last year that the agency had flagged con­cerns about the ab­sence of safe­ty da­ta be­yond the 12-week stretch test­ed in the clin­ic. It al­so didn’t help ini­tial­ly that there are oth­er prod­ucts for the con­di­tion, less­en­ing the ur­gency of an ap­proval.

The agency doesn’t pub­lish CRLs and nev­er of­fered an ex­pla­na­tion for its re­ver­sal, an agency stan­dard on in­di­vid­ual com­pa­nies. 

Their estra­di­ol vagi­nal in­serts will be sold as Imvexxy.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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