People with severe migraine can soon expect the deliverance from their torment. An anti-body injection, which is approved in the United States, in the autumn, also available from us. Experts speak of a real therapeutic Revolution.
Pulsating-throbbing pain in the head, Nausea, dizziness, sensitivity to light, and flu-like symptoms for up to 72 hours – so migraine for millions of people in Germany. Some of them are just distressed sporadically, the disease has nothing to do with “normal” headaches. Others suffer 15 to 20 days in the month of the attacks. And, especially bad, many of the Standard medications to help. A new therapy gives hope, which is now closer each day: an anti-body injection, once a month under the skin or administered, to suffocate migraine attacks in the approach.
Antibodies Erenumab stands in front of the admission
Of four quite similar-acting substances that have proved in clinical trials to be effective, has taken almost all of the hurdles of the admission: The antibody is Erenumab under the brand name “Aimovig” in the United States are already on the market. The European medicines Agency Ema has given their recommendation for approval and with a positive decision, the European Commission, at the latest, expected in mid-September. The General availability in Germany manufacturer Novartis is aiming in the late autumn.
“So the introduction to the market is complex,” says a company spokeswoman. This also means that the price for the new drug to negotiate. “He is an anti-body for sure significantly higher than for all previously for migraine prevention available active ingredients. A number would be but at the Moment pure speculation.“ Also in the USA due 6.900 Dollar (almost 6000 euros) per year would not scale for Germany.
New Era migraine therapy
During the clinical test phase, the experts were impressed. The preventive injection against the pain was a “new step in the history of mankind,” said around the end of 2017 Professor Hartmut Göbel, chief physician and head of the pain clinic in Kiel, in front of the “world on Sunday” for sure. “For ten years, it was quiet in the research, but now much is really to be expected,” says migraine expert.
At the end of November 2017, the researchers have presented the final results to two of the 2000 subjects tested ingredients in the “New England Journal of Medicine”. Was Erenumab Concerned with episodic migraine (people who suffer from on a regular basis, but less than 15 days of attacks) was administered. The antibody Fremazumab was injected to patients with chronic migraine. For this compound but there is still no admission efforts.
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Intervention in the migraine mechanism
The special feature of the new compounds is that they intervene directly in the mechanism of the disease, not just symptoms fight. The success was possible because we understand the mechanism of migraine is better by now: The Hypothalamus plays in the migraine-emergence of a supporting role. In this area of the midbrain the autonomic nervous system is controlled.
The study showed that the Hypothalamus revealed about 24 hours before a migraine attack strong activity. When the seizures started then, could be detected on the images of magnetic resonance imaging (MRI) of the Hypothalamus reinforced with the point of origin of one of the most important nerve of the brain, the Trigenimus-nerve Association.
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Antibodies turn off the migraine-peptide CGRP
This is the point of origin of the nerve the so-called CGRP-substance accumulates, a key concept in migraine research. This neuro – peptide in the technical language of Calcitonin gene-related petide called can blood vessels strong, wide, what leads to pain. Patients suffer from chronic migraine, it is in your blood permanently elevated CGRP level is undetectable.
The new active compounds to combat this substance, such as pain physicians, Göbel declared that: “The antibodies block the receptors for CGRP, so to speak, the signal receiver, the other transmitter substances”. Erenumab sets directly to the receptors.
There is no fear of side effects
The results of the study: If the injections were administered monthly, and had it at 41 percent of the subjects with chronic migraine. They had only half as many, or even fewer pain days per month. In the case of episodic migraine Affected syringes could lead to significantly less pain days.
In contrast to other migraine agents, such as the so-called Triptans, beta-blockers, or antidepressants, the antibody showed no side-effects splash in the Central nervous system. Also in the long term, the antibodies appear to have no serious side effects. On the head of pain Congress in San Francisco at the end of June were presented to the 2018 results, the side effects for the soon to be available to migraine-filled syringe in the Placebo, there were.
Syringe does not replace the precautions of the patient
With all the anticipation of the injection for migraine, warns Professor Göbel in front of a fallacy: “you could give the patient the feeling that I need nothing more”. However, this is a misconception.
Migraine patients should not forget, according to Göbel, that your brain is in spite of the syringes, particularly sensitive and vulnerable to stimuli. To quickly and intensively through the nervous system, flow cells would be weakened – and in contrast to that, the new active substances could not fight sufficient.