Wednesday, June 11, 2008

New Arthritis Drug Fares Well In Trials

A novel pharmaceutical drug for the treatment of rheumatoid arthritis (RA) has been found to be both safe and effective in its late Stage III trials. The drug is reportedly being developed by Johnson & Jonson and Schering-Plough.

Golimumab, the drug being tested is an immunosuppressive drug that targets tumor necrosis factor alpha (TNF-alpha), which is a pro-inflammatory molecule.

Objectives Met During Trials

During the first two trial the anti-TNF medicine was successful in reducing symptoms of (RA) by at least 20 percent, which was also the main objective of the trials.

Further, a unique result of the trial was that after 14 weeks of drug therapy, the drug provided relief even to those patients whose condition didn't respond well to some standard anti-TNF medicines.

This very fact raises hopes for some 20% of the patients whose conditions aren't controlled well by the existing drugs. The muslculoskeletal system drug once launched, is meant to be delivered to patients on a monthly basis. Eventhough it doesn't belong to a completely new class of drugs, the molecule is surely a freshman to the family of anti-TNF formulations.

The most commonly reported side effect of the drug was a mild irritation where it was injected, overall it was well accepted in patients.

Unmet Objectives During Trials

Despite the overall success of the drug, it fell short of meeting the objectives of another Stage III trial, wherein it couldn't relieve symptoms by at least 50% in patients who hadn't been treated previously with methotrexate, an old oral medicine. However, the symptomatic relief by at least 20 percent was replicated successfully.

The Concerns It seems that a point to watch out for, is that how the musculoskeletal system drug actually fares when compared to the already existing anti-TNF compounds? Reportedly, the trial hasn't been carried out "head to head" against other anti-TNF drugs.

Another concern pertains to the very mechanism that these drugs employ to provide relief. While they do provide relief, they do it at the expense of altering how the immune system behaves? So the relief is derived at the risk of infection. Finally, recently a more cautious and stringent FDA swung into action to test whether some widely available blockbuster anti-TNF drugs actually raise the risk of cancer in children and young adults or not?

Reportedly, the FDA had got about 30 reports of cancer in children and young adults who had been on these drugs for about 10 years. The cancers mostly included lymphomas, and the rest were leukemia, melanoma and also those affecting other organs.

According to the FDA, the drugs already carry a warning of potential linkage to cancer, the evidence isn't conclusive though. However, long-term studies are already underway by the Belgian pharma company UCB, but the results wouldn't be out till 2019.

Significance Of Novel Drugs For Drug Companies

The anti-TNF compounds are blockbuster drugs, reported to be worth upto US$ 3 billion in annual sales. Formulation of newer drugs is perhaps most important to the sustainability and profitability of drug makers, especially the big companies. More so because most of the patents of their blockbusters are slated to expire between 2010 – 2012.

On the whole, newer and more effective drugs are much needed by patients and drug companies alike, at the same time they need to be so devised that their side effects are reduced to a minimum if not completely eliminated.

No comments: