Novartis withdraws EU approval request

Novartis has announced the temporary withdrawal of its application for European Union approval of lumiracoxib (Prexige) while the company awaits the outcome of the European Medicines Agency (EMEA) safety review of all selective COX2 inhibitors. Although Novartis said it is 'committed' to the drug, given the current review of the category it felt that it was prudent to withdraw the filing for the time being, in spite of the drug being approved in 21 countries already. Lumiracoxib is thought to be one of Novartis' most important new drugs to help bolster earnings, and the company is relying on older products, such as the angiotensin II receptor antagonist valsartan (Diovan) for hypertension, to maintain sales growth until lumiracoxib is approved. The EU review is expected to be completed in the first half of 2005.

Lilly launches clinical trials registry

Eli Lilly has launched a publicly accessible registry of its clinical trials on its website (http://www.lillytrials.com). The registry will contain results from all Phase I–IV trials for its marketed drug products, and Lilly said it will post initiation data about all company-sponsored Phase II–IV clinical trials, as well as a comprehensive description of the trial design and methodology for each study.

FDA delays release of Critical Path Initiative

With issues such as safety concerns about marketed drugs needing to be urgently addressed, the publication of the FDA's Critical Path Initiative on the drug development process has been delayed. The report — which will identify key bottlenecks in the drug discovery and development process, and suggest ways to overcome these obstacles — was scheduled to be released this autumn, but will now not be available until early next year.

Antibody treatment for MS approved

Biogen Idec and Elan Pharmaceuticals have received FDA approval for their multiple sclerosis drug natalizumab (Tysabri, formerly known as Antegren). The antibody, which is the first new type of treatment for multiple sclerosis in eight years, targets α4 integrins on the surface of the blood cells that are thought to have a major role in causing the damage to the nervous system in multiple sclerosis, and interferes with their movement from the bloodstream into the brain and spinal cord. Biogen Idec said the FDA objected to the more familiar name Antegren because it was too similar to some existing drugs, such as Integrillin (Millennium).

Further warnings on antidepressants

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has requested new labelling on antidepressants. The agency wants to strengthen warnings about suicidality with selective serotonin-reuptake inhibitors (SSRIs) and the effects of drug withdrawal. The MHRA has also said that venlafaxine (Effexor; Wyeth) could cause irregular heart rhythms, withdrawal symptoms and have a higher rate of death from overdose than similar drugs. Wyeth responded that the changes are not consistent with scientific evidence. The FDA said that it does not find there is justification at this time for increased warnings or labelling changes for venlafaxine or SSRIs.

Female testosterone patch rejected by advisory committee

A testosterone patch for female sexual dysfunction (Intrinsa; Proctor & Gamble) has potential long-term risks that currently outweigh its benefits, said an FDA Advisory Committee. The committee voted unanimously against approval of Intrinsa due to safety concerns, such as a potential relationship to cardiovascular events and breast cancer. In the wake of findings from the Women's Health Initiative, hormonal combinations might need more extensive safety data, said the committee. The difference between placebo and Intrinsa was about one additional satisfying sexual episode per month. However, a P&G blinded exit interview of 132 patients from the two pivotal trials found a 52% meaningful response rate among the women treated with Intrinsa compared with 31% on placebo. The committee voted 14 to 3 that the effect of Intrinsa was clinically meaningful, but small.

Calcium-channel blocker benefits halts trial

A long-term study of the calcium-channel blocker amlodipine (Norvasc; Pfizer) has been stopped early because of the drug's significant benefits. The Europe-wide ASCOT study on ∼20,000 patients was designed to compare a combination of Norvasc with the angiotensin-converting enzyme inhibitor perindopril over a combination of the beta-blocker atenolol and thiazide diuretic bendroflumethiazide in preventing cardiovascular events in patients with hypertension. As yet, Pfizer hasn't released any data on the observed benefits of amlodipine.