FDA On The Offensive Regarding New Alzheimer’s Drug

A woman sitting on the ground with another person.


The Food and Drug Administration’s Commissioner Robert Califf has defended the agency’s approval of the new Alzheimer’s drug called Aduhelm.  This follows an investigation by House Democrats which found close cooperation between the drug’s sponsors and regulators.  The findings were made by the Oversight and Reform Committee and the Energy and Commerce Committee which found an unusual number of meetings between Biogen Inc. and the FDA.  The FDA also co-authored with the company a briefing document presented to outside advisors, which is very unusual.  Unfortunately, the drug was pulled off the market because Medicare refused to cover the expensive drug.

New Blood Pressure Reduction Device Requires No Medication

A stethoscope and heart on the table.


A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a new study.  However it missed its goal, producing an insignificant blood pressure result of only 2 points more than those in the study that didn’t have the procedure done.  Despite falling short of the study’s main efficacy goal, Medtronic is still moving forward with its application to the Food and Drug Administration to approve the device.  If the FDA approves it, the device could offer a new, non-medication treatment for people who have high blood pressure.  “This could be the biggest thing we’ve ever done because hypertension is the No. 1 contributor to death,†Medtronic CEO Geoffrey Martha told The Wall Street Journal.

FDA Rejects Two Cancer Drugs Developed In China

A doctor and patient looking at a book


The Food & Drug Administration has denied approval of two proposed new cancer drugs which were developed in China.  The FDA issued a letter to Hong Kong-based Hutchmed Ltd. denying permission to market the drug ufatinib, which is approved in the Chinese market to treat pancreatic and neuroendocrine tumors.  It also notified China-based Shanghai Junshi Biosciences Co. and its U.S.-based partner Coherus BioSciences Inc. that it denied its application to sell the drug toripalimab, which treats nasopharyngeal cancer.  The FDA asked the companies to change their quality-related processes at which time the FDA will reexamine the applications.  However, the FDA did note that two clinical trials Hutchmed conducted in China for ufatinib didn’t support approval so that company may have to go back to the drawing board on clinical trials as well.  FDA officials have commented publicly recently that they were not happy with the quality of drug studies conducted in China and that it was unclear whether the results would be applicable to U.S. patients.

 

Eli Lilly Gets Bad News About Its New Lung Cancer Drug Tuvut

A woman with glasses and a tie dye shirt smoking.


In a 14:1 vote, a panel advising U.S. drug regulators said Eli Lilly & Company and its Chinese partner (Innovent Biologics) needs to conduct more studies on a proposed new lung-cancer drug called Tuvut before giving FDA approval.  The panel was concerned about the tests done on the drug in China and said it had significant shortcomings and its results were not applicable to U.S. patients who would use the drug.  This is due in part that the study participants didn’t reflect the diversity of the U.S. population and they also suggested that Innovent undercounted adverse events.

FDA officials have recently cited concerns about the quality of drug studies conducted largely in China and whether the results in Chinese patients are directly applicable to patients in the U.S.  The most recent recommendation by the panel advising the FDA isn’t just a setback to Eli Lilly, but is likely a shot over the bow to let U.S. drug companies know that they need to more carefully screen their Chinese partners or they may risk having important drugs see a long delay before gaining FDA approval or even being denied FDA approval altogether.

 

 

 

FDA Approves Two COVID-19 Vaccines

A vial of influenza vaccine next to two syringes.


At last, the FDA has approved both the Pfizer and the BioNTech vaccines.  They are no longer approved only for experimental use which will shoot down one of the last excuses that anti-vaxers have been using as an excuse not to get vaccinated.  This is where the rubber meets the road and those not getting vaccinated are going to have to try and come up with another excuse for doing what the majority of Americans have done—get vaccinated against the coronavirus.  Shortly after the approval, the Pentagon announced that it would require all active-duty military to be vaccinated (only 64% now are) and President Biden put the pressure on private companies to do the same.  “Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions to do that,†he said.  Johnson & Johnson and Moderna are expected to submit paperwork to get full approval by the end of the year.  This is definitely great news as hospitalizations from COVID-19 are surging as the Delta variant continues to spread.

https://www.wsj.com/articles/fda-approves-pfizer-biontech-covid-19-vaccine-for-people-16-and-older-11629726322?mod=djemwhatsnews

Dr. Fauci Says COVID-19 Vaccines Might Be Fully Approved By Month End

A man in white lab coat and glasses.


Dr. Anthony Fauci said on Sunday that he believes that the Food and Drug Administration (FDA) could give full approval for COVID-19 vaccines by the end of the month.  This could spur some non-vaccine people more amenable to getting vaccinated, slowing down the rapidly growing rate of infection.    Fauci also warned in his “Meet the Press†interview that although the delta variant is troublesome, a new variant may emerge which would make the pandemic even more problematic and longer lived.  It could also cause more businesses to decide to require employees to get vaccinated or find another job. There are now more than 44K Americans in the hospital with COVID-19, up 30% from just a week ago, according to Johns Hopkins University.

https://www.usatoday.com/story/news/health/2021/08/08/us-infections-100-k-cdc-florida-joe-biden/5524511001/