The term “efficacy nod” is a little confusing, the FDA term is “reasonable expectation of effectiveness”, which makes more sense to me, it sounds like the drug has enough promise that the FDA thinks its worth continuing testing. They may not have actual effectiveness data yet, just evidence that it’s safe and a reasonable explanation for why it might work.
That’s what I thought too, but the FDA’s website indicates that a company that gets conditional approval can sell a drug where they have adequately demonstrated safety but have not demonstrated efficacy. The company can then sell this provisionally approved drug for 4.5 years after receiving conditional approval without having to demonstrate efficacy.
That said, conditionally approved drugs have to have a disclaimer on the packaging that says “Conditionally approved by FDA pending a full demonstration of effectiveness under application number XXX-XXX.”.
I personally don’t expect very high efficacy, and I do expect that Loyal will sell the drug for the next 4.5 years. However, as long as Loyal is clear about the nature of the approval of the drug, I think this is basically fine. People should be allowed to, at their own expense, give their pets experimental treatments that won’t hurt them and might help them. They should also be able to do the same for themselves, but that’s a fight for another day.
I personally don’t expect very high efficacy, and I do expect that Loyal will sell the drug for the next 4.5 years. However, as long as Loyal is clear about the nature of the approval of the drug, I think this is basically fine. People should be allowed to, at their own expense, give their pets experimental treatments that won’t hurt them and might help them. They should also be able to do the same for themselves, but that’s a fight for another day.
Agreed! Beyond potentially developing a drug, think Loyal’s strategy has the potential to change regulations around longevity drugs, raise profits for new trials, and bring attention/capital to the longevity space. I don’t see many downside risks here unless the drug turns out to be unsafe.
It can change regulations around longevity drugs in both directions. If the product gets brought by people and found ineffective, people will complain that the FDA was not stringent enough and the FDA has the motivation to be more stringent.
Are there examples of ineffective drugs leading to increased FDA stringency? I’m not as familiar with the history. For example, people agree that Aducanumab is ineffective, has that cause people to call for greater scrutiny? (genuinely asking, I haven’t followed this story much).
There are definitely examples of a drug being harmful that caused increased scrutiny. But unless we get new information that this drug is unsafe, that doesn’t seem to be the case here.
The report included three recommendations that it believed FDA should immediately implement, including:
Keeping proper documentation of the agency’s interactions with drug companies
Creating clear protocols for when the agency can create joint presentations with companies
Updating its guidance for the development of new Alzheimer’s drugs
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.
That’s what I thought too, but the FDA’s website indicates that a company that gets conditional approval can sell a drug where they have adequately demonstrated safety but have not demonstrated efficacy. The company can then sell this provisionally approved drug for 4.5 years after receiving conditional approval without having to demonstrate efficacy.
That said, conditionally approved drugs have to have a disclaimer on the packaging that says “Conditionally approved by FDA pending a full demonstration of effectiveness under application number XXX-XXX.”.
I personally don’t expect very high efficacy, and I do expect that Loyal will sell the drug for the next 4.5 years. However, as long as Loyal is clear about the nature of the approval of the drug, I think this is basically fine. People should be allowed to, at their own expense, give their pets experimental treatments that won’t hurt them and might help them. They should also be able to do the same for themselves, but that’s a fight for another day.
Agreed! Beyond potentially developing a drug, think Loyal’s strategy has the potential to change regulations around longevity drugs, raise profits for new trials, and bring attention/capital to the longevity space. I don’t see many downside risks here unless the drug turns out to be unsafe.
It can change regulations around longevity drugs in both directions. If the product gets brought by people and found ineffective, people will complain that the FDA was not stringent enough and the FDA has the motivation to be more stringent.
Are there examples of ineffective drugs leading to increased FDA stringency? I’m not as familiar with the history. For example, people agree that Aducanumab is ineffective, has that cause people to call for greater scrutiny? (genuinely asking, I haven’t followed this story much).
There are definitely examples of a drug being harmful that caused increased scrutiny. But unless we get new information that this drug is unsafe, that doesn’t seem to be the case here.
There was a congressional inquiry that then tasked the FDA to:
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.