Editor note: On 09/30/2004, Merck the maker of Vioxx, issued a worldwide recall, halting sales of the drug. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs Fallout from the Vioxx recall will continue for years to come.
Dateline: January 13, 1999
Vioxx Gets Priority Review Status
This week the U.S. Food and Drug Administration (FDA) assigned six-month priority review status to Vioxx, the COX-2 inhibitor manufactured by Merck & Co. for the treatment of osteoarthritis and pain.
The news about Vioxx along with the recent FDA approval of Monsanto's (Searle division) Celebrex has the two drug companies poised to battle. Merck and Monsanto each hope to capture the majority of the market and reach the projected $1 billion in annual sales.
By receiving FDA approval first, it might seem as though Celebrex has the advantage over its competition.
However, makers of Celebrex were disappointed by the FDA's insistence that the drug carry the same warning label regarding side effects as older non-steroidal anti-inflammatory drugs (NSAIDS).
Labeling
Merck, the makers of Vioxx are hoping to obtain a less severe warning label. One of the reasons Merck was behind Monsanto in applying for FDA approval was because it waited for the results of longer term studies. Vioxx is submitting results from 68 studies involving almost 10,000 patients. If Vioxx can actually obtain the lesser warning label, the advantage may shift to Merck.
Monsanto is confident that it can obtain a labeling change after more patients take the drug and demonstrate its claim of being less harmful to the gastrointestinal tract. Merck also may gain advantage by getting approval for Vioxx to be taken once a day, whereas Celebrex is prescribed once or twice a day for osteoarthritis and twice a day for rheumatoid arthritis.
Availability
Monsanto was expected to begin shipping Celebrex to pharmacies around January 14th. By mid-February it is projected that all retail pharmacies will have Celebrex available. The average cost to patients will be $2.42 a day, which is comparable to currently available NSAIDS. Monsanto reportedly has said it will fill prescriptions for free for indigent patients without health insurance.
Other companies, including Smith-Kline Beecham and American Home Products Corporation's Wyeth-Ayerst, are developing COX-2 inhibitors as well. So in time there will be more than just Monsanto and Merck battling for position in the COX-2 inhibitor drug market.
Related Resources
Sources: Monsanto To Start Shipping Celebrex Within 10 Days, Reuters, 1/4/99; Monsanto Victory Temporary In Arthritis Drug War, Cincinnati Post, 1/4/99; FDA Grants Priority Review For Vioxx, PRNewswire, 1/11/99
First published: 01/13/1999
