‘Pomalyst’ Is Proposed Brand Name For Pomalidomide
Published: Jan 7, 2013 12:25 pm
Celgene has proposed ‘Pomalyst’ as the trademarked brand name for pomalidomide.
The name was made public this morning in a press release by Celgene (NASDAQ: CELG), the company developing pomalidomide. The press release contains information about the company's expected financial results for 2012 and forecasts for 2013 and later years.
In the press release, Celgene refers to pomalidomide primarily by its new proposed brand name, Pomalyst. This is the first time the company has used the proposed brand name in a public document or presentation.
Pomalidomide belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalidomide) – two drugs that Celgene already markets as myeloma treatments in the United States and internationally. Celgene is developing pomalidomide as a potential new treatment for multiple myeloma and for myelofibrosis, a disorder of the bone marrow in which the marrow is replaced by scar (fibrous) tissue.
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The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are both currently reviewing applications for the approval of pomalidomide in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma patients who have received at least two prior therapies.
The FDA is required to make its decision about pomalidomide’s new drug application by February 10, 2013.
Pharmaceutical companies such as Celgene discuss a new drug’s proposed brand name with the FDA during the agency’s review of a drug. Brand names are not typically finalized, however, until close to the time a drug is approved by the FDA and is ready to be launched for general use.
Celgene's announcement of Pomalyst as the brand name for pomalidomide can therefore be interpreted as a sign the company is anticipating FDA approval of pomalidomide sometime in the near future.
There was a time when Celgene was considering using the brand name "Actimid" for pomalidomide. Many older press releases and other documents from the company make use of that brand name.
However, the company stopped using Actimid as a potential brand name for the drug several years ago, and it has been mum about the final brand name for pomalidomide until today's press release.
For more information, please see the Celgene press release.