Aim: Migraine is one of the most prevalent and disabling medical
illnesses. Preventive drugs are used to reduce the frequency, severity,
and duration of attacks. Most patients were no longer on their
medication due to contraindications or poor clinical response.
Therefore, there is need for novel prophylactic agents for migraine. New
preventive treatments are those of the class of Calcitonin Gene Related
Peptide (CGRP)-targeting therapies. We aimed to assess the real level of
therapeutic innovation of these new drugs. Methods: The information on
the new drugs was collected from several documents, including the
European public assessment reports (EPARs). The level of therapeutic
innovation was assessed with the algorithm published by some of us in
2006. Results: All new approved drugs (eptinezumab, galcanezumab,
fremanezumab, erenumab) are indicated for the prophylaxis of migraine in
adults who have at least 4 migraine days for month. All these drugs have
been tested only in comparison to placebo. Their level of therapeutic
innovation was only modest, i.e. the lowest value of our algorithm.
Conclusion: The new monoclonal antibodies of the class of CGRP targeting
therapies have been authorized with efficacy data only against placebo.
They do not offer additional clinical benefits compared to available
therapies for the prevention of migraine attacks, with the exception of
a lower frequency of administration and a more rapid effect. All this
assigns to these drugs only a modest role in therapy according to our
algorithm for therapeutic innovation with a significantly higher cost
than similar therapies.