From Annerose Fischer-Bucher
Since mid-year, new preparations for chronic migraines have been marketed, which are mainly offered by three companies in Germany. Among them is a new group of drugs for the treatment of chronic migraine. What happens to a newly approved biotech drug? Andrea Nägele, Senior Advisor of the Neurological Clinic in Göppingen Christophsbad.
What is migraine?
Dr. Andrea Nägele: A migraine is a violent attack, usually one-sided, pulsating headache accompanied by nausea and vomiting. It can take from 4 to 72 hours. Unlike headache, it increases during physical activity. Photophobia, sensitivity of noise and odor are other accompanying symptoms. Since there are many types of headache, it is not every headache, as someone likes to call it, a migraine headache.
What kind of migraine are there?
We distinguish acute and chronic forms of migraine with some characteristic subtypes, for example, the familial form associated with hemiplegia. Chronic form of migraine is defined as a headache for more than 15 days a month.
What does aura mean?
These are symptoms of 5-20 minutes, even before the onset of headaches. This can be visual disturbances in the form of flickering lights, spots, lines or even numbness and tingling, which then follow the headache. Migraine with aura represents about 10 to 15 percent, people without aura about 85 percent.
What is the percentage of patients with headache in your clinic?
Approximately 15 to 20 percent of our patients come with the headache symptom. Headache may be a symptom of many neurological conditions such as cerebral hemorrhage, meningitis, sleep apnea syndrome or tension-type headache caused by muscle tension. Our daily work and expertise is to recognize the type of headache and treat it specifically.
What is the treatment for chronic migraine?
To date, beta-blockers, antidepressants, botulinum toxin and epilepsy drugs that could affect the frequency of headache were available for this group of patients as a drug prophylaxis. Only 20% of patients remained in these therapies. Most have to stop medication due to side effects.
A drug prescribed by biotechnological antibodies has been approved by the European Medicines Agency (EMA) since July 2018. How does it work?
The new drug specifically for chronic migraine is called Erenumab. It inhibits the CGRP receptor (peptides related to a calcium gene). The CGRP is a messenger for messages. Exact operation is not yet known. However, it is known that CGRP sensitizes the nerves, dilates the blood vessels and affects the treatment of pain.
How do you rate success?
According to the studies, especially patients with a high level of CGRP benefit from this new drug. The number of days of headache decreased by half in this patient group. Erenumab is injected once a month under the skin. Side effects include light redness at the injection site and mild constipation.
Do you use the new biotech drug?
Of course. Patients have a high level of discomfort and a significantly reduced quality of life due to the large number of days of headache. Erenumab is the only drug approved in Germany so far. Fremandezumab, galacuzumab and eptignumab are likely to follow.
What is the difference between
a conventional medicine and a biopharmaceutical?
In a biopharmaceutical, biotechnological agents use genetically modified organisms that form proteins or nucleic acids. They can be programmed to attach to specific cells in the body and therefore are extremely effective and more selective than chemical molecules. So far, such drugs are already being used in the treatment of cancer.
Biotech drugs are difficult to manufacture and costly. Will such a medicine also be available for patients who are health insured?
If a patient is in the reporting group, the fund pays. The cost is about 6000 euros per year. I suspect that because of the high costs, the refund will be out of the budget.