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Patrick
2024 Mar 18, 2:40pm
Patrick
2024 Mar 18, 2:40pm
https://palexander.substack.com/p/mccullough-twc-scientist-reminds
China’s Stranglehold Over America’s Drug Supply; Rosemary Gibson Author of "China Rx: Exposing the Risks of America's Dependence on China for Medicine"
“Millions of Americans are taking prescription drugs made in China and don't know it--and pharmaceutical companies are not eager to tell them. This is a disturbing, well-researched wake-up call for improving the current system of drug supply and manufacturing. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk.
The FDA sent over a quick rejection letter on Thursday to Eli Lilly regarding its anti-PD-1 antibody sintilimab, further crushing the hopes of any companies looking to bring cheaper follow-ons based only on Chinese data.
The complete response letter (CRL) follows a nearly unanimous Oncologic Drugs Advisory Committee (ODAC) recommendation against sintilimab’s approval, which was intended as a first-line treatment for people with nonsquamous non-small cell lung cancer. The FDA also revealed at the meeting that the company submitted the application without consulting regulators before the trial concluded, and misrepresented interactions with the agency during its presentation.
“The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint,” Lilly said in a statement on Thursday.
As far as next steps for sintilimab, which is approved in China, Lilly said it’s assessing the situation with Innovent on the US market.
Lilly is unlikely to be the only company affected by this CRL, as FDA’s oncology chief Rick Pazdur wrote in a recent Lancet article — and the FDA said in its presentation at the adcomm — that there are about 25 such applications with China-only data either under review, planned to be submitted or currently under development.
Most notably, the biotech EQRx is developing a large suite of drugs in-licensed from Chinese companies with the goal of disrupting pricing models in the US. One of its two lead programs is an anti-PD-L1 antibody sugemalimab, which EQRx has said it could price at a 40% to 50% discount. Back at January’s J.P. Morgan conference, EQRx outlined plans to test sugemalimab in a “US-led” study testing the antibody against other approved checkpoint inhibitors, in an apparent response to the FDA’s stance.
Lilly had attempted a similar price disruption strategy, with oncology head Jacob Van Naarden announcing ahead of the adcomm that the company had plans to discount the drug by as much as 40% compared to other PD-1s on the market.
So far, each of the seven anti-PD-1 and anti-PD-L1 drugs approved by the FDA has been priced the same at $150,000 per year.
While the FDA has repeatedly noted that it does not take pricing into account when reviewing drugs, it often accounts for competition, as with the generic drug market and its running tally of first generics.
https://endpts.com/fda-serves-up-a-quick-rejection-of-china-only-data-with-a-crl-for-lillys-pd-1/?source=patrick.net