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Saturday, October 1, 2022

The F.D.A. has granted approval to the anti-wrinkle drug Daxxify, which is a competitor to Botox

Botox has had a near monopoly on the market for anti-wrinkle treatments for many decades. The Food and Medicine Administration (FDA) has granted approval to a new drug that may delay the development of wrinkles on the face for around six months.

Revance Therapeutics, the company that developed the new treatment known as Daxxify, made the announcement that it had been given approval on Thursday morning. The company stated that the effects of the treatment, which are administered via injection into the face along worry lines, lasted longer than those of other products currently available on the market.

The new therapy, which is very similar to Botox and is manufactured by AbbVie, is a neuromuscular blocking drug that effectively freezes wrinkles. It is also a botulinum toxin, which, when administered according to the instructions, does not show up in the bloodstream of the patient.

About eighty percent of the treatment providers saw no or mild facial lines four months after injection, and about fifty percent saw the effect through six months. These results were presented in studies that were submitted to the F.D.A. The treatment significantly exceeded the effect of a placebo by a wide margin.

Dr. Balaji Prasad, an analyst who covers specialty pharmaceuticals for Barclays Investment Bank and who stated that the medication was the most significant advance in the $3 billion field of facial injection drugs since Botox was first approved decades ago, said that the medication was the most significant advance in the field since Botox, which now dominates 70 percent of the market.

Dr. Prasad emphasised that patients do not have to visit the clinic once every three months. In a world where time is of the importance, it is incredibly helpful to have a product that has a lengthy duration factor.

In an interview on Thursday, Mark Foley, the chief executive officer of Revance Therapeutics, said that the business spent many years attempting to find an efficient neuromuscular blocking agent that could be administered to the skin in a manner that did not need the use of a needle. In the course of the procedure, it was discovered that using peptide technology to maintain the formula’s stability was superior to the more traditional methods of using animal protein or human serum. Because of this, the medicine was granted permission, and he said that the business has already began testing it for a wide range of medical conditions.

Mr. Foley said that this development “also opens up the door for what we can accomplish with medicines.” When you consider conditions such as migraines, cervical dystonia, and overactive bladder, there is a significant potential in the medical field as well.

In 2010, the Food and Drug Administration gave its approval for the use of Botox as a treatment for chronic migraines.

According to the findings of one of the Revance studies that were submitted to the F.D.A. for the aesthetic use of Daxxify, users suffered higher adverse effects than those who were given a placebo. Six percent of users experienced headaches, and two percent of users acquired drooping eyelids.

The Food and Drug Administration (FDA) issued a warning about the possibility of general muscular weakness or difficulty with breathing associated with the use of therapies based on toxins, but said that no such symptoms were seen with Daxxify.

The approval process for the medicine was fraught with challenges. According to Dr. Prasad, the F.D.A. postponed an examination of the production facility because travel restrictions were enforced during the coronavirus epidemic. Revance, which has its headquarters in Nashville, had previously anticipated to get certification in November 2020.

According to the documents maintained by the FDA, the inspection was carried out in June 2021 and resulted in the identification of issues with the company’s working cell bank and quality control process. A working cell bank is a collection of cells that includes the drug’s active component. According to Mr. Foley, such worries were put to rest after the corporation established a fresh cell bank that was operational.

Jonathan James
I serve as a Senior Executive Journalist of The National Era
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