Anti CGRP molecules to make a paradigm shift in the Migraine treatment landscape

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Migraine is a neurological disorder often characterized by moderate to severe pain on one side of the head. The disease can be very intimidating in nature and vary in range and frequency for different patients. A typical Migraine attack in a patient can last starting from a few hours to a multiple numbers of days depending on type and intensity of the disease in a patient. The frequency of the attacks also varies for different patients. While some of the patients might experience attacks very infrequently during a typical month, other patients might experience the attacks almost every day or every alternate day.

Migraine is a widely prevalent disease and is known to be one of the three most prevalent diseases in the world and the disease is prevalent in around 14% of the entire world population. In the US, the prevalence of the disease is around 12% of the US population. It is more prevalent in women and impacts the women 3 times more as compared to men which come down to affecting around one in every five women across the globe.

The disease can impact the quality of life to a great extent in the patients. Patients are usually debilitated and frustrated most of the times and usually try to hide their condition from the outside world because of the fear of being ignored and hence try to cut off their social life and interactions pushing themselves in the world of loneliness.

Treatments for Migraine have been historically classified in two major categories. The first category of treatments is Acute treatments which are the treatments used by patients when they are encountering attacks and these treatments help in reducing the intensity of pain in the attacks. The second category of treatments is a Prophylactic treatment which are preventive therapies typically used by patients to reduce the frequency of attacks.

Presently Acute treatments are most widely used treatments amongst the patients. This is because of multiple reasons. First, because Migraine as a disease is not considered as a life-threatening disorder or a disease leading to severe disability, by physicians and the patients, and hence not much focus is there on the preventive treatments. Second, patients with the disease tend to visit a General Physicians rather than a Neurologist because patients are not able to differentiate between a normal headache and a Migraine headache. Third, all the preventive therapies currently approved were not researched for Migraine specifically and hence have somewhat lower efficacy. Some of the examples of preventive therapies used are Anti Epileptics, Anti-Depressants, Beta blockers, Blood pressure medications, Muscle relaxants etc. Due to excessive usage of Acute treatments, there have been multiple side effects observed in patients. To take an example, Triptans which are widely used Acute therapies are associated with serious Cardio Vascular side-effects which can stay long-term with patients.

However, with the research and prospective launch of Anti CGRP molecules, the treatment paradigm is expected to change, and the treatment focus is expected to shift from Acute therapies to preventive treatments. This is primarily due to the increased focus of patients and physicians on Migraine as a disorder because of increased awareness and also because of the superior Mechanism of Action associated with the anti CGRP drugs. The anti CGRP drugs are the monoclonal antibodies which target the CGRP (calcitonin gene-related peptide) molecule in the body, a molecule which is believed to play an important role in causing the disease in a patient. The 4 anti CGRP molecules by Amgen, Teva, Lilly and Alder respectively have shown superior efficacy and well-tolerated safety profiles during their clinical trials and the products are expected to disrupt the market space in the coming few years.

Fremanezumab by Teva:

Fremanezumab is an Anti CGRP molecule and is researched by Teva Pharmaceuticals. Fremanezumab has already been filed in the US market and is expected to be approved and launched in the market by 3rd quarter of 2018. Fremanezumab has shown superior efficacy during the Phase II and Phase III stages of its trial design. Also, Fremanezumab has been well tolerated by the Episodic and Chronic Migraine patients during its clinical trials and no major adverse events have been observed during the trials. The product is expected to be one of the key products ever launched in the market.

Erenumab by Amgen and Novartis:

Erenumab is an Ant CGRP molecule and the product was initially researched and originated by Amgen Inc. However the product would be co-marketed by Amgen and Novartis Pharmaceuticals based on a co-marketing agreement between the two firms. Erenumab has already been filed in the US and the EU markets and regulatory action by the FDA is expected no later than May 17, 2018. The product would be launched under the brand name of Aimovig and would be the first to launch into the anti CGRP space. The product is expected to have a huge impact on the market in the initials months of its launch.

Galcanezumab by Lilly:

Galcanezumab, another anti CGRP, is researched by Eli Lilly. The product has already completed its Phase III clinical trials and has been filed in the US and EU markets and is expected to be launched in the market towards the end of 2018. During its clinical trials, the product has displayed efficacy in the reduction in Migraine days and no major side effects have been observed.

Eptinezumab by Alder:

Eptinezumab is being researched and would be marketed by Alder BioPharmaceuticals. The product is currently in the Phase III stage of the approval process and would be a late entrant to the anti CGRP preventive medication space as it would be launched by the end of 2019.

All these anti CGRP molecules have almost displayed similar efficacies and safety profiles during their clinical trials. The products are expected to gain majority shares in the market given their superior efficacy and safety profiles as compared to the existing therapies. However, the only factor which is to be seen in the near future is the price at which these products would be available, because it is currently speculated that the price for these drugs would range between $8000 to $9000 per year in the US market, which is really costly in a highly genericized Migraine market.