FDA Asked To Approve Valdecoxib
Updated December 29, 2014.
Editor note: On 11/19/2001, the FDA approved Bextra (valdecoxib). On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline March 24, 2001
Food and Drug Administration) for approval of Valdecoxib, a second generation version of Celebrex. The indications for Valdecoxib, the third COX-2 inhibitor developed by Pharmacia, include:acute pain dysmenorrhea osteoarthritis rheumatoid arthritis
If Valdecoxib is approved by the FDA, the advantage in the rivalry between Pharmacia and its competitor Merck (the makers of Vioxx, the COX-2 inhibitor FDA-approved 6 months after Celebrex) might swing even more in the direction of Pharmacia.
In 1999, Celebrex (originally developed by G.D.Searle and later obtained by Pharmacia) was approved as the first COX-2 inhibitor, a new class of drugs to treat arthritis. By the end of 2000, Pharmacia had submitted parecoxib sodium for FDA approval. Parecoxib sodium is the first injectable COX-2 inhibitor and is currently under FDA review for acute pain management.
If the FDA approves Bextra (valdecoxib), Pharmacia will become the first company to offer a COX-2 drug in both oral and injectable forms.
Parecoxib sodium is a "pro-drug" for Valdecoxib. A pro-drug is a drug which is rapidly converted in the body to the active form.
In 2000, the COX-2 selective inhibitor Celebrex earned $2.6 billion. With Valdecoxib, Pharmacia projects annual sales could surge from $2.6 billion to $6 billion. Merck, reportedly was only $440 million behind Pharmacia in annual sales. At times Merck seemed to be narrowing the gap, but the momentum is again behind Pharmacia. Not only is Pharmacia appearing strong because of the pending approval of Valdecoxib, but also because of other indications for Celebrex such as:
Familial Adenomatous Polyposis (FAP) (a rare and serious inherited disorder) ankle sprains
And then there is the news of Vioxx causing elevated blood pressure whereas Celebrex does not. Pharmacia expects a 12-month review period by the FDA for Valdecoxib. Co-developed by Pharmacia and Pfizer, Valdecoxib will be co-promoted by both companies.
Bextra (Valdecoxib) COX-2 Selective Inhibitors NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) Arthritis Medications
Sources: Pharmacia Submits New Drug Application for Valdecoxib, Pharmacia Corp., March 23, 2001; Winner Of The Week: Pharmacia, Forbes.com, March 23, 2001; Pharmacia Seeks OK For Second Generation Arthritis Drug, Reuters, March 23, 2001
First published: 3/24/2001
Editor note: On 11/19/2001, the FDA approved Bextra (valdecoxib). On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline March 24, 2001
FDA Approval Being Sought
On March 23, 2001, it was announced that Pharmacia has submitted a new drug application to the FDA (U.S.Food and Drug Administration) for approval of Valdecoxib, a second generation version of Celebrex. The indications for Valdecoxib, the third COX-2 inhibitor developed by Pharmacia, include:
If Valdecoxib is approved by the FDA, the advantage in the rivalry between Pharmacia and its competitor Merck (the makers of Vioxx, the COX-2 inhibitor FDA-approved 6 months after Celebrex) might swing even more in the direction of Pharmacia.
Parecoxib Sodium
In 1999, Celebrex (originally developed by G.D.Searle and later obtained by Pharmacia) was approved as the first COX-2 inhibitor, a new class of drugs to treat arthritis. By the end of 2000, Pharmacia had submitted parecoxib sodium for FDA approval. Parecoxib sodium is the first injectable COX-2 inhibitor and is currently under FDA review for acute pain management.
If the FDA approves Bextra (valdecoxib), Pharmacia will become the first company to offer a COX-2 drug in both oral and injectable forms.
Parecoxib sodium is a "pro-drug" for Valdecoxib. A pro-drug is a drug which is rapidly converted in the body to the active form.
COX-2 Selective Inhibitors
In 2000, the COX-2 selective inhibitor Celebrex earned $2.6 billion. With Valdecoxib, Pharmacia projects annual sales could surge from $2.6 billion to $6 billion. Merck, reportedly was only $440 million behind Pharmacia in annual sales. At times Merck seemed to be narrowing the gap, but the momentum is again behind Pharmacia. Not only is Pharmacia appearing strong because of the pending approval of Valdecoxib, but also because of other indications for Celebrex such as:
And then there is the news of Vioxx causing elevated blood pressure whereas Celebrex does not. Pharmacia expects a 12-month review period by the FDA for Valdecoxib. Co-developed by Pharmacia and Pfizer, Valdecoxib will be co-promoted by both companies.
Related Resources
Sources: Pharmacia Submits New Drug Application for Valdecoxib, Pharmacia Corp., March 23, 2001; Winner Of The Week: Pharmacia, Forbes.com, March 23, 2001; Pharmacia Seeks OK For Second Generation Arthritis Drug, Reuters, March 23, 2001
First published: 3/24/2001
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