The lifecycle of a drug is its path from discovery to market. This journey involves basic research, the discovery of a compound, preclinical development, increasingly complicated clinical trials in human subjects, regulatory approval, and post-market surveillance. This entire process can take up to 15 years and cost hundreds of millions of euro. (1) For every drug that gets approved by the Food and Drug Administration (FDA) in the US, 5,000 to 10,000 compounds don't make it through the process, making the whole process very costly and financially risky. (1) A drugs lifecycle ends when or if it is taken off the market unless as in the case of natalizumab it is put back on the market again.
The development of natalizumab is a unique story. It is a recombinant humanized monoclonal antibody that binds to the α4 integrin and is used to treat multiple sclerosis (MS). It was granted approval in 2004 by the FDA, only twelve years after its molecular target was cloned. (2) Unfortunately, several patients treated with natalizumab were diagnosed with progressive multifocal leukoencephalopathy (PML) after its initial approval, and the sale of natalizumab was suspended. The drug was reintroduced to the market in …show more content…
(2) These much larger studies aim to confirm efficacy, monitor side effects and compare natalizumab to the standard treatment used for MS at the time, which was IFNβ-1a. In the two-year AFFIRM study, the annual relapse rate was significantly reduced by natalizumab. (2) The SENTINEL study looked at the combination of natalizumab and IFNβ-1a and found that it significantly reduced the relapse rate when compared with the standard treatment. (2) These studies provided the evidence needed to satisfy regulators that natalizumab met the legal requirements to be approved for
The development of natalizumab is a unique story. It is a recombinant humanized monoclonal antibody that binds to the α4 integrin and is used to treat multiple sclerosis (MS). It was granted approval in 2004 by the FDA, only twelve years after its molecular target was cloned. (2) Unfortunately, several patients treated with natalizumab were diagnosed with progressive multifocal leukoencephalopathy (PML) after its initial approval, and the sale of natalizumab was suspended. The drug was reintroduced to the market in …show more content…
(2) These much larger studies aim to confirm efficacy, monitor side effects and compare natalizumab to the standard treatment used for MS at the time, which was IFNβ-1a. In the two-year AFFIRM study, the annual relapse rate was significantly reduced by natalizumab. (2) The SENTINEL study looked at the combination of natalizumab and IFNβ-1a and found that it significantly reduced the relapse rate when compared with the standard treatment. (2) These studies provided the evidence needed to satisfy regulators that natalizumab met the legal requirements to be approved for