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FDA launches Coronavirus Treatment Acceleration Program (CTAP). But can CTAP result in lower quality products? – what it means for the biotech and pharma industry? – Elexes
Elexes Medical Consulting

CTAP – a step towards acceleration of therapies for COVID 19

After the emergence of COVID 19, FDA began working with academia, industry,  and federal health partners like the Department of Health and Human Services and soon started the CTAP program, released on March 31, 2020. As a part of this program, FDA would use every tool at their disposal to 

– expedite new therapies and get those to sick patients

– support research for further evaluating if the therapies and countermeasures are safe and effective for treating patients, in other words helping or hurting the patients over time  

FDA is very clear that supporting the acceleration of products to help people during this pandemic is their top priority. Stephen M. Hahn, MD, commissioner of the FDA said. “We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time.”

How is CTAP being implemented?

In the midst of several approvals, pre-approval meetings, online surveillance for compliance, and review of regular updates, FDA has done the following to ensure priority is being given to COVID-19 therapies and diagnostic tools: 

  • Rearrange and redeploy medical and regulatory staff to serve on review teams dedicated to COVID-19 therapies
  • Streamline processes and operations to facilitate receiving inquiries and requests from  developers and scientists
  • Provide resources to researchers and health care providers so that they could submit an emergency request for the use of investigational products

What are the current therapeutic options for COVID 19?

Many therapies are planned to be explored. These include: 

  • Antiviral drugs like remdesivir to treat the virus and people affected by it
  • IL-6 (interleukin-6) receptor inhibitors to reduce lung inflammation and improve lung function 
  • Convalescent plasma and hyperimmune globulin, antibody-rich blood based therapeutic products derived or prepared using the donated blood of recovered people to evaluate if therapy with these could lessen the severity or shorten the length of the illness
  • Chloroquine and hydroxychloroquine either with or without other medications to evaluate its antiviral effect on COVID 19 

Maintaining a balance between speed and quality 

In order to speed up the process of approval and yet maintain the worldwide known FDA approval gold-standard, the following steps are being taken as a part of the CTAP:

  • Complement traditional clinical studies with real world data sources to derive safety and efficacy decisions 
  • Collect and analyse information on illness patterns and treatment outcomes by advancing relationships with private and public sectors 
  • Leverage established information on the safety profile of certain products that can have a new application for the treatment of COVID 19

While there is criticism of the application of Chloroquine and hydroxychloroquine for COVID 19 patients due to the limited data for such an application in humans and lack of well-designed clinical trials, the reasoning behind continuing this quest for a therapeutic option is also a need of the hour. As a result currently under the US FDA, 10 therapeutic agents are in active trials and 15 therapeutic agents are in planning stages. 

For exploring the regulatory pathway for your company’s potential therapeutic product or to know about the statistics in the therapeutic area, please feel free to email us at helen@elexes.com

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