New AIDS drug awaits green light for European launch

Date: 27/03/03

By Karen Carstens

HIV-positive patients in Europe should soon benefit from a new drug recently approved by the European Agency for the Evaluation of Medicinal Products (EMEA).

"The agency has a history of accelerating approval of AIDS drugs," said EMEA spokesman Martin Harvey.

The EMEA's scientific body, the European Committee for Proprietary Medicinal Products (CPMP), recently recommended the granting of a marketing authorisation for Fuzeon.

Jointly developed by Basel-based pharmaceuticals giant Roche and the North Carolina biopharmaceutical company Trimeris, Fuzeon is part of a new generation of HIV drugs called "fusion inhibitors". These prevent the entry of viruses into healthy "host" cells.

According to Roche, Fuzeon is intendedfor use with other antiretroviral drugs - these block replication of the human immunodeficiency virus (HIV), which causes AIDS.

Although not a cure, continued use of the drugs significantly slows the disease's progression.

The CPMP's recommendation will now be put to the European Commission for approval.

Harvey said the EMEA hopes the Commission will move as swiftly as possible to get the new drug onto the market, estimating that this would take about two months if the EU executive acts fast.

William Burns, head of Roche Pharmaceutical, said: "This is excellent news for European HIV patients who are becoming resistant to currently available treatments. Fuzeon represents a major advance in the fight against HIV."

Fuzeon was also approved this month by the Food and Drug Administration (FDA) in the United States. Submissions for marketing authorisations have also been made in Australia, Canada and Switzerland.

Unlike the FDA, the London-based EMEA lacks legal powers to give "fast-track" approval to specific drugs.

But it has done so with AIDS drugs and other urgently needed medicines on an ad hoc basis.

Member states and the European Parliament still need to approve new pharmaceuticals legislation that would give the EMEA similar rights to the FDA for such fast-track approvals in future, Harvey said.

"It's like a line of products that have formed a queue, and the FDA can choose people to jump ahead of the queue," he added.

The EMEA, established by the European Commission in 1995 to streamline the approval of new pharmaceutical products, relies on fees charged to drugs companies, along with funding from Brussels.

HIV-positive patients in Europe should soon benefit from a new drug recently approved by the European Agency for the Evaluation of Medicinal Products.