Boehringer Mannheim licensee Ercopharm AS has launched the beta blocker carvedilol in Denmark for the add-on treatment of patients with symptomatic heart failure who are already on standard therapy with diuretics, ACE inhibitors, digoxin and/or vasodilators. This is the first world market for this indication. The drug has been available there since 1994 for hypertension.
In addition, BM's partner SmithKline Beecham has been granted approval in Spain to market the product for CHF. The product will be launched as soon as pricing approval is obtained, which could be in the next several weeks. In May, a US advisory panel recommended against approval of the drug, citing the lack of a confirmatory clinical trial (Marketletter May 13).
Aside from Spain and Denmark, carvedilol has been approved for CHF in Israel and Mexico, and is available in 28 countries for hypertension. Contrary to reports circulating in January (Marketletter January 29), neither SB nor BM have launched the drug in Mexico for CHF, because only one of three strengths of carvedilol tablets is approved (25mg). For CHF, two lower-strength formulations (6.25 and 12.5mg) are required. A similar situation exists in Israel.
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