Botox: US agency releases use of competing toxin – 09/09/2022 – Equilibrium

The FDA (the agency that regulates food and drugs in the United States) has approved a new drug that reduced the appearance of facial wrinkles for about six months, spurring competition in a market that has been dominated by Botox for decades.

Revance Therapeutics, maker of the new treatment, Daxxify, announced approval on Thursday morning, saying its effects — by injecting it into the face along fine lines — lasted longer than other products on the market. .

Like AbbVie’s Botox, the new treatment is a neuromuscular blocking agent that essentially freezes wrinkles. It is also a botulinum toxin which, when used as directed, is not detected in the patient’s bloodstream.

In studies submitted to the FDA, the treatment far exceeded the effect of a placebo. About 80% of treatment providers saw little or no fine lines four months after applications and about half saw results within six months.

Balaji Prasad, who covers specialty pharmaceuticals as an analyst at Barclays Investment Bank, said the drug was the most significant advance in the facial injection drug business — a $3 billion industry — since Botox, which now dominates 70% of the world. sector, and was first approved decades ago.

“Users don’t need to apply it once every three months,” Prasad said. “In a world where time is of the essence, having a product with a long-lasting factor is extremely useful.”

Mark Foley, chief executive of Revance Therapeutics, said in an interview Thursday that the company had spent many years trying to find an effective neuromuscular blocking agent that could be applied to the skin without a needle.

In the process, he found a way to keep the formula stable with peptide technology instead of the animal protein or human serum that was normally used. This led to the approval of the product, which he said the company has already begun testing for a variety of medical purposes.

“It also opens the door to what we can do with therapeutics,” Foley said. “If you think about migraine, cervical dystonia, overactive bladder, there’s also a huge medical opportunity.”

The FDA approved Botox as a treatment for chronic migraine in 2010.

One of Revance’s studies submitted to the FDA for the cosmetic use of Daxxify revealed that users had more side effects than those given a placebo: 6% experienced headaches and 2% developed a droopy eyelid.

The FDA warned of the potential for general muscle weakness or breathing difficulties with the use of toxin-based treatments, but said none of these symptoms were seen with Daxxify.

The drug had a difficult road to approval. Revance, based in Nashville, Tennessee, initially expected approval in November 2020, but the FDA has delayed an inspection of the manufacturing site due to travel restrictions imposed during the coronavirus pandemic, according to Prasad.

In June 2021, the FDA conducted the inspection and discovered problems with the company’s quality control process and its working cell bank, a set of cells that contain the drug’s active ingredient, according to agency records.

Foley said those concerns were resolved once the company put a new cell bank into operation.

Translated by Luiz Roberto M. Gonçalves

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