The EMEA (European Medicines Agency) can recommend a product is given Conditional Approval, the CHMP (Committee for Medicinal Products for Human Use) bases a positive opinion on the data available. Usually this data is not sufficient to award a full approval, but is of such a positive nature and the drug of such obvious benefit to a group with high unmet medical need that they will allow it to go to market whilst the clinical data is strengthened.
The FDA has a similar approval process.
The CHMP make this recommendation on the understanding that the company will undertake an agreed programme of works aimed at strengthening the data package. The company are under an obligation to fulfill this programme of work. In order to ensure that they do the conditional approval is reviewed annually until full approval is granted.
This can be an important regulatory avenue for companies that have relatively well known drugs that are being targeted at a new indication, as long as there is considerable unmet medical need, and very strong indication of safety, and a good indication of ethicacy. Because you can in effect go to market after phase 2, and the revenues raised can help fund your phase 3 programme, it can accelerate your development and maintain your equity standing.
If conditional approaval in pursued in an orphan indication you could be in the market place with a very limited number of patients and perhaps a single clinical trial.
During our work as development consultants we have pursued this path for clients and it is an effective tool for maximising the outcomes of R&D spending but also improtant in ensuring patients with a despirate need for drugs can get access as quickly as possible.
If you would like to know more about this please feel free to get in touch.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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