How does the regulatory pathway for orphan drugs differ?

The regulatory pathway for orphan drugs is distinct primarily because these drugs are developed to treat rare diseases and conditions, which affect a limited percentage of the population. Due to the challenges associated with commercial viability in these cases, regulatory agencies have established specific incentives to encourage the development of orphan drugs. These incentives can include tax credits for clinical research, assistance in the drug development process, and an extended period of market exclusivity upon approval.

The existence of a unique approval process means that orphan drugs benefit from a regulatory environment designed to facilitate their development and availability to patients in need. This process aims to mitigate the economic hurdles faced by manufacturers when investing in treatments for conditions that might not be profitable in a traditional market scenario.