The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Last month, Par’s lawyers at Axinn called on the FDA to refrain from approving any generics for Vasostrict due to the potential for certain stability and other specifications that could cause concerns with impurities or other safety issues.
But FDA points out at the top of its response that vasopressin has been marketed as a therapeutic agent for nearly a century.
‘Pitressin, a natural vasopressin product developed as an extract of the bovine posterior pituitary, was first introduced in 1928,’ the agency said.
What’s more is that Par only won FDA approval for vasopressin in the first place, in 2014, because of the FDA’s drug safety initiative at the time to encourage manufacturers to obtain the agency’s approval for old, unapproved drugs.
In addition to the denying the petition, FDA said that it ‘does not on its face raise valid scientific or regulatory issues’ and ‘it appears to have been submitted with the primary purpose of delaying approval of Eagle’s ANDA and fails to raise valid scientific or regulatory issues. The Agency intends to refer this matter to the Federal Trade Commission (FTC), which has the administrative tools and the expertise to investigate and address anticompetitive business practices.’
This kind of action from the FDA is rare to see, as lawyer Kurt Karst at Hyman, Phelps & McNamara noted on Twitter, and it may be part of a wider collaboration between the FDA and FTC to put companies on notice over attempts to block future generics.
Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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For the first time, Biogen released details Thursday on how it intends to prove that its by turns celebrated and maligned drug Aduhelm can actually slow the decline of patients with Alzheimer’s, as required by the FDA.
The biotech said it will launch a global 1,300-person trial next May that will randomize early-stage Alzheimer’s patients to receive either Aduhelm or placebo. It will probably take about four years for the trial to generate results, the company said, pushing a final answer to 2026.
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Renee Aguiar-Lucander, Calliditas CEO
Since its founding, Calliditas has wagered it could bring to market a new formulation of an oral steroid to treat a rare kidney disease. And on Wednesday afternoon, its bet paid off.
The FDA granted accelerated approval to the biotech’s delayed-release budesonide capsules, Calliditas announced, waving through a new treatment for the reduction of proteinuria in primary IgA nephropathy. Wednesday’s approval came after regulators delayed the PDUFA date by three months, as Calliditas said the agency requested further analyses.
A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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Thomas Lingelbach, Valneva CEO
Two weeks ago, Valneva pushed back against a study that found its candidate, VLA2001, was the only one out of seven tested vaccines that didn’t significantly boost protection when given to volunteers who had two doses of the Pfizer/BioNTech mRNA shot.
Valneva said the participants had been given booster doses after a shorter interval than usual — and vaccines made from inactivated viruses, such as its candidate, typically require a longer period of time to be effective.
From L-R: Luigi Naldini, Genenta CEO Pierluigi Paracchi and Genenta CMO Carlo Russo
After years of developing its gene therapy for cancer on the outskirts of biotech, Genenta has landed on Nasdaq as the first Italian biotech on the American exchange.
Genenta’s IPO is small compared to what you usually see these days, but the $36 million — or $40 million if all options are exercised — in gross proceeds will allow Pierluigi Paracchi’s crew to take its current proof-of-concept trial to fruition and pave the way to Phase II, fund long-term monitoring of patients, pay for preclinical research and manufacturing, while leaving enough money to run the actual Phase II trial slated to start in 2023 (the business development and admin team also gets some).
https://endpts.com/fda-seeks-ftc-action-after-rejecting-petition-to-block-first-generics-for-decades-old-vasopressin/
