Drug against cancer: Approval should be faster

by time news

In the case of drug candidates with high medical benefits, companies can obtain preferential treatment from the regulatory authorities. For drugs that receive breakthrough therapy status from the US Food and Drug Administration (FDA), the duration of the study is then reduced by around 20 to 25 percent. A “breakthrough designation” means that the drug receives increased attention and priority from the authorities and approval is granted more quickly, explains Kremer. Recently, for example, the German pharmaceutical company Boehringer Ingelheim received several of the coveted quick approvals.

Also read: Cancer drug – healing from within

Consultant and biochemist Kremer also names concrete measures how companies can change their organization in order to get their medicines to market faster. For example, little “white space”: Because before a drug is on the market, it has to go through several clinical studies – initially on a few healthy patients, finally in phase 3 on hundreds, thousands or sometimes even tens of thousands of sick patients. The evaluation of a study then often takes months, if not years – until then the start of the next test phase is delayed. Researchers speak of the “white space” between the study phases. This period can be shortened, for example, through faster evaluations and structured processes until the start of the follow-up study and corresponding scenario planning.

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