Tag: Regulatory approval

Developing a new drug is a lengthy and challenging process, with statistics indicating that only about 1 out of 5,000 compounds entering the preclinical phase eventually becomes an approved drug. Understanding **what are the steps of drug design** is crucial for appreciating the immense scientific and financial investment required to bring new medicines to market.

Over 90% of all solid-dose drugs on the market today use microcrystalline cellulose (MCC) as a binding agent. While its widespread use might suggest a direct approval, the regulatory path for a substance like microcrystalline cellulose is different from that of an active drug and depends on its specific application.

In January 2023, the U.S. Food and Drug Administration (FDA) initially rejected Eli Lilly's application for accelerated approval of its Alzheimer's drug, donanemab, citing a limited number of patients with adequate long-term data. This was not the only regulatory hurdle the treatment would face, as the European Medicines Agency (EMA) also refused authorization later due to an unfavorable risk-benefit assessment.