Milla’s Mestinon Generic Wins FDA Approval, Will Launch in US

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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The U.S. Food and Drug Administration (FDA) has approved Milla Pharmaceuticals’ generic version of Mestinon (pyridostigmine bromide) for treating the symptoms of myasthenia gravis (MG).

The new generic, available as a syrup, is expected to soon launch in the U.S.

This approval of Milla’s abbreviated new drug application (ANDA) marks the company’s third ANDA approval in the last year, and the fourth for Alter Pharma, of which Milla is a subsidiary. An ANDA is a formal request that a company must submit when seeking approval of a generic form of an already approved brand-name therapy.

ANDAs are “abbreviated” because they typically do not require any clinical trial data; the original version of the medication would already have been proven safe and effective.

However, such applications must show evidence that the generic treatment is a bio-equivalent of the brand-name therapy. This means that it is absorbed and moves through the body on the same time course and in the same concentrations as the brand-name product.

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“Once might be luck, twice could still be coincidence, three times for sure is a pattern but the fourth time — especially in such a short period of more or less two years — can only be proof of the fact that we are doing it fast and right, which is an absolute necessity if we want to realize our group’s mission to make affordable, high-quality medicines available to all,” Filip Van de Vliet, Alter’s CEO, said in a press release.

MG is an autoimmune disorder in which the body produces self-reactive antibodies that attack the neuromuscular junction, the place where nerve cells and muscles communicate.

At this junction, a signaling molecule called acetylcholine is released from nerves and binds to receptors on muscle cells to facilitate that communication. Most MG cases are driven by antibodies against acetylcholine receptors, which hinder the crosstalk between nerves and muscles.

Acetylcholine that is not attached to a receptor is degraded by an enzyme called acetylcholinesterase. The active ingredient in Mestinon — pyridostigmine — blocks this enzyme, ensuring that there is enough acetylcholine to bind to any available receptors on muscle cells.

In so doing, the treatment lessens symptoms of muscle weakness that are characteristic of MG.

Mestinon has been approved in the U.S. since 1955 for people with all MG types, and is marketed by Bausch Health. It is available in tablet or syrup forms.

Other generic versions of pyridostigmine have been approved and are available in syrup, tablet, and injection formulations. Milla’s new generic formulation will be supplied as a 60 mg/5 mL syrup.

Milla is focused on developing generic versions of prescription therapies. The company says its goal is to deliver high-quality medicines at more affordable prices.

The FDA in August 2021 approved the company’s generic version of sodium acetate, an additive used when people are given intravenous (into-the-vein) hydration to ensure adequate salt levels. Its generic form of magnesium sulfate, used to prevent and control seizures during certain pregnancy complications, was approved last November.

2021 Myasthenia Gravis Survey Results

BioNews Survey Infographic

Myasthenia Gravis News conducted a survey from Feb. 11-March 28 to gain greater insight into the characteristics of the MG community and disease management. Results of the survey have now been published. Click on the image to view the infographic, and click here to read the story.