Amgen recently released a positive result for their experimental trial drug to treat chronic migraine. The company announced that their candidate drug erenumab or also known as AMG 334, showed statistically significant result for the prevention of chronic migraine.
The company had collaboration with Novartis, a Swiss drug maker in the development of the medication. If the drug wins regulatory approval, Amgen will sell the drug in US, Japan and Canada while Novartis will hold sales right in Europe and in other parts of the world.
AMG 334: Competitive Drug for Migraine?
The AMG 334 is an antibody protein that is produced by the body’s immune system. It can determine and kill cells that can cause diseases like the bacterial cells. Theoretically, AMG 334 can help prevent the onset of migraine by inhibiting the calcitonin gene-related peptide receptors or CGRP. High levels of CGRP molecules are thought to be associated with migraines.
The experimental drug will be used for the prevention of chronic migraine. The study showed that the candidate drug can reduce the number of monthly migraine attacks compared with the placebo. The drug was tested for 12-weeks and 667 patients were given two doses of erenumab.
Before the experimental trial, the participants in the study had experienced an average of 18 days of migraine per month. Patients who were given 70 milligram or 140 mg injected once a month had a reduction of migraine days to around 6.6 days. Those who took the placebo had a 4.2 reduction days. Thus, Amgen noted that both control groups has statistically significant results.
Both Amgen and Novartis are looking forward to discuss these developments with the global regulators. Kristen Davis, spokesperson of Amgen noted in an interview that the Phase 3 episodic data that they are expecting in H2 could support both the episodic and chronic indications that are indicated by global regulators.
An analyst from JPMorgan also noted that the results were not surprising considering that the results showed consistency of the treatment effect of CGRP inhibitors. They also noted that AMG 334 has a lot of potential. It could be one of the main pipelines of Amgen considering the huge commercial potential of episodic and chronic migraine.
The company is also expecting to deliver the result of the late-stage study for episodic migraine later this year. A chronic migraine is defined as having at least 15 migraine headaches per month for over 3 months, while episodic migraine is having 4 to 14 headache days per month
The firm noted that its effective treatment effect could even surpass its competitor. Alder Pharmaceuticals and Eli Lily are also working on developing products that target migraines.
An analyst from Citi estimated that AMG 334 could generate$1.5 billion sales for Amgen. The drug could also provide an upside of $8 per share.
Amgen is expecting to release a more detailed report including the secondary goals at a later date. They are aiming for at least 50% reduction of monthly migraine days and a change in cumulative headache hours every month.
Good News for Millions of Migraine Sufferers
Amgen Research Chief, Sean Harper noted that there are around three to seven million Americans who suffers migraine headaches. Migraine is a severe form of headache where patients experienced nausea, vomiting and intense sensitivity to light and sound.
The company noted that the safety profile of erenumab is similar to placebo. The usual side effects of the drug include upper respiratory infection and site pain on injection.
The consistency of treatment effect of erenumab has made it one of the most promising drugs in treating migraine. If granted an approval, it will be able to help millions of people suffering from chronic and episodic migraines.