Study says Fremanezumab helps chronic migraine patients miss out on fewer activities

Migraine doesn’t care if you have a big project at work or your sister is getting married. Your plans are quickly replaced by rest and a dark room when an attack hits. Those days spent resting with Migraine add up, especially for those with Chronic Migraine, or 14 or more Migraine days a month,.

Because the burden of Chronic Migraine is so great, effective treatments that help people get out of bed and back into life are worth their weight in gold. Clinical studies for fremanezumab, a new anti-CGRP therapy, show that the drug lessens the frequency of attacks enough to allow patients with Chronic Migraine to experience more functional days. That means more days to be productive at work, more days spent with your family, and more days spent enjoying life without pain.

Fremanezumab is one of four therapies currently in development for Migraine prevention that target the neurotransmitter CGRP (calcitonin gene-related peptide.) Each therapy has published positive date for Phase 3 clinical trials for episodic Migraine and fremanezumab and erenumab have shown positive results for Chronic Migraine, as well. The anti-CGRP therapies are likely to be expensive, so studies that show effectiveness for those most severely affected by Migraine are especially useful.

Fremanezumab effectively reduces headache days and Migraine days in patients with Chronic Migraine at two dosages

Study. Two subcutaneous dose regimens for fremanezumab have proved equally effective and well tolerated in a placebo-controlled study in patients with chronic migraine (1).

Both monthly dosing (fremanezumab 675mg followed by fremanezumab 225mg at months 2 and 3) and quarterly dosing (fremanezumab 675 mg at month 1, then placebo at months 2 and 3) significantly reduced monthly headache days (MHDs) of at least moderate severity and monthly migraine days compared to placebo.

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Results. During the 12-week period after the first dose:

  • Monthly headache days (MHDs) were reduced by 2.5 days with placebo, compared to reductions of 4.6 days with monthly fremanezumab (p<0.0001) and 4.3 days with quarterly fremanezumab (p<0.0001)].
  • Fremanezumab-treated patients also had statistically significant reductions in the number of monthly migraine days during the 12-week period after the first dose, for both dosing regimens (monthly -5 days, quarterly -4.9 days p<0.0001) vs. placebo (-3.2 days), and during the four weeks after the first dose, for both dosing regimens (p<0.0001).

    fremanezumab

    Effective preventative treatments are big deal – and long overdue- for families affected by Chronic Migraine. Image: Unsplash

The most common adverse event in the study was injection site reaction.

Source: American Academy of Neurology Congress, April 26, 2018

What Will FDA Approval Mean to People with Migraine?

Those with episodic Migraine and those with Chronic Migraine are eagerly awaiting access to anti-CGRP drugs. If real-world use of fremanezumab tracks with its clinical trial performance, patients can expect significantly greater effectiveness than existing preventive therapies with fewer side effects. Chronic Migraine patients can expect to experience fewer headache and Migraine days within the first four weeks of treatment. We can also expect a battle with insurance companies to cover the anticipated hefty price tag.

Pushback against the price has already begun as US buyers urge manufacturers to lower the price and offer a refund program if the drug doesn’t work as expected. Amgen and Novartis’ formulation is estimated at $10,000, and it will likely set the price for other anti-CGRP meds. Teva, the manufacturer of fremanezumab, said it was “evaluating the pricing environment and will announce a price after approval. 2) ”

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Patient-led groups like the Coalition for Headache and Migraine Patients (CHAMP) are advocating for patients who are frequently disabled by Migraine and need access to the anti-CGRP medications like fremanezumab. For many patients, access to this class of medications can have a significant effect on their ability to show up for work and take care of their families.

FDA Ruling on Fremanezumab pushed back to 2019

FDA approval of fremanezumab was recently pushed back to 2019 due to issues with a processing plant in South Korea, putting it third in the race for approval. Aimovig (erenumab), the formula developed by Amgen and Novartis, is expected to be the first to be approved on May 18, 2018. Eli Lilly’s formulation, galcanzenumab, is expected to get the green light later this year. Once the drugs are approved in the US, other countries will likely follow the FDA’s lead on the safety and efficacy as they make decisions for availability in their respected countries.

Want to make sure you’re prepared when new drugs hit the market? This article will help you get ready

Comments? Are you eager to try the anti-CGRP drugs?

Image: Unsplash