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| Farber | For our purposes, the story of nevirapine begins in 1996, when the German pharmaceutical giant Boehringer Ingelheim applied for approval of the drug in Canada. The drug had been in development since the early 1990s, which was a boom time for new HIV drugs. Canada rejected nevirapine twice, once in 1996 and again in 1998, after the drug showed no effect on so-called surrogate markers (HIV viral load and CD4 counts) and was alarmingly toxic. In 1996, in the United States, the FDA nonetheless gave the drug conditional approval so that it could be used in combination with other HIV drugs. |
| Gallo | Farber states that Canada rejected nevirapine twice on the grounds that it did not show efficacy with respect to surrogate markers. She says that the FDA nevertheless registered it. Nevirapine has been shown to be effective using surrogate markers of CD4 and viral load count. (See the FDA package insert for details.) Also see the meta-analysis of nevirapine and efavirenz referred to above. 38 |
| RA | In 1998 the Canadian Deputy Minister of Health (the top bureaucrat in Health Canada) wrote to the Canadian Minister of Health “With respect to the antiretroviral Viramune (nevirapine), this drug has indeed been approved in several countries. Viramune was approved by the US FDA under the Accelerated Approval process…Approval of Viramune by the EMA [European Medical Agency] was associated with post-approval commitments for further clinical study…The review of the new drug submission for Viramune did not reveal any conclusive effects on clinical end points nor on surrogate marker end points [e.g. CD4 counts or Viral load] to support the benefit of Viramune in treating patients with HIV disease. The efficacy of Viramune was not clinically significant when evaluated against internationally recognized standards of efficacy for drugs used in the treatment of HIV. There are, in addition, safety concerns associated with Viramune use in clinical trials. On March 6, 1997, a Notice of non-compliance (NON) was issued by the Therapeutic Products Programme. On July 2, 1997, the manufacturer filed a response to the NON. In the absence of scientific evidence of efficacy and concerns relating to safety, the data available for Viramune are judged to be inadequate to support the clinical benefit of the drug. Canada, under considerable political pressure, later approved the drug. |
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