[Adaptive drug licensing: A chance for patients?].
In recent years, various options have been discussed to accelerate the approval of new drugs, especially for conditions with high unmet needs. There is a trade-off between the earlier availability of new treatment options and a potentially higher safety risk of drugs which have not been investigated in long-lasting clinical trials and a broader patient population. It must also be taken into account that clinical trial data and results must be sufficient to allow for the reimbursement of the new treatment option. The difficult process of weighting the benefits against the potential risks of an accelerated drug approval should be discussed between patients, regulatory authorities, HTA institutions and pharmaceutical companies. Patients might benefit from a fair, balanced accelerated approval.
Medizinischer Direktor, SANOFI, Berlin, Germany. Electronic address: Dieter.Paar@sanofi.com.
W Dieter
WD
Paar
D017277:Drug Approval; D005858:Germany; D006801:Humans; D008009:Licensure, Pharmacy
Arzneimittelsicherheit; Arzneimittelzulassung; Drug approval; HTA Institutionen; HTA organizations; Zulassungsbehörden; accelerated approval; adaptive licensing; beschleunigte Arzneimittelzulassung; drug regulatory agencies; drug safety; malignes Melanom; metastatic melanoma; primary hypercholesterolemia; primäre Hypercholesterinämie