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3 FDA updates all clinical trials should take note of

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The clinical research industry is now finally back-up and running after months of standstill; and with this, the FDA is powering through months of application backlog. With only 15% of treatments in phase 1 clinical trials making it to market every year, most products under review will not meet the standard required by the organisation. However, in recent weeks, a select few pharmas have met the mark and promise further developments in a range of healthcare areas; and this is something that we should all, regardless of background or experience, should be excited about.

It’s crucial, now more than ever, that research sites are regularly updated on FDA procedure and verdict as one pharma’s success could be the key to unlocking another. Today, we take a look at some of the most recent developments in everything FDA; and consider how these clinical studies might spark some inspiration for your own clinical protocol and treatment options. Check out our breakdown below.

“Breakthrough” cardiovascular disease treatment awaits market approval

It’s promising news for Regeneron’s evinacumab as the FDA confirms the release date of their market application. Back in 2017, the organisation classed the compound as a breakthrough therapy for a cholesterol-targeting disease, hypercholesterolaemia (HoFH). The illness that drives up the blood pressure of around 1,300 people in the US has been notoriously difficult to treat in previous years, with existing cholesterol-lowering treatments struggling to combat the

onset of the disease. Evinacumab, an antibody compound that tackles the illness head on, looks set to be made widely available after February 11th 2021, the final date for the FDA’s review results to be released.

Regeneron’s treatment has some impressive trial results to back up its application. In phase 2 clinical trials, the antibody achieved 50% reductions in LDL cholesterol and has a proven ability to cut blood lipids. As of yet, there is no existing data that proves the treatment itself can reduce the progression of heart disease in patients; however, the compound’s ability to cut blood lipids is thought to be at the heart of the treatment’s efficacy.

In addition, the biopharma has a number of other phase 1 clinical trials currently underway that could see the treatment being used for a range of related conditions. These clinical studies are looking to target less severe inherited disorders and non-inherited forms that aren’t meeting treatment targets with other available medications.

More options for asthma treatments

Roche’s new self-administration option for their asthma treatment is now under review by the FDA as the company’s application for the procedure was accepted early this month. Xolair, Roche’s brand of omalizumab, is currently FDA approved for administration by a healthcare provider; so a self-administration option could open up the drug to approximately 25 million people in the US with the condition. As the treatment is the only biologic approved which is designed to target and block immunoglobulin E, the potential for wider means of clinical protocol could be promising news for those with moderate to severe versions of the disease.

In previous clinical studies, Roche’s treatment has passed the test. Through rigorous clinical research, which includes eight phase 3 clinical trials, just under half a million patients have been treated with Xolair since its first approval back in 2003. With such consistent results so far, it looks like Roche is on the right track for success.

Approval for muscle-degeneration treatment

A Japanese company, NS Pharma, have recently been given the all-clear by the FDA for their new therapy tackling Duchenne muscular dystrophy. Viltepso (viltolarsen) has been approved in patients who have confirmed mutation of the gene thought to be a major cause of the illness. At present, NS Pharma’s product can be used to treat around 8% of DMD patients and previously approved DMD drugs are not proven to change the course of the disease.

From a wider perspective, the compound still has a lot of potential for future clinical studies. Viltepso has been tested in two clinical studies with a total of 32 patients, all of whom were male and had genetically confirmed DMD. In the studies, dystrophin production increased around 5% from start to finish.The FDA assessed that this increase is “reasonable likely” to predict a clinical benefit –something that is not easy to measure in small-scale clinical studies. As part of the accelerated approval process, the FDA requires NS Pharma to carry out further clinical trials to confirm clinical benefit.

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  • Interested in finding out more? Get in touch with us here, and check out our archives for all our top tips and tricks on running successful clinical trials in today's constantly changing industry.

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