Rising Proportion of New and Modified Indication Approvals

In an effort to extend product life cycles and generate larger and longer revenue streams per product, pharmaceutical and biotechnology companies have stepped up their efforts to seek approval for new or modified indications of already approved drugs.

A recent study conducted by the Tufts Center for the Study of Drug Development finds that the number of new or modified indication approvals following the original new drug approval (NDA) increased 17% between the periods 1998 to 2003 and 2004 to 2009. Original NDAs as a proportion of total drug approvals continues to decline gradually. The number of new drug approvals for pediatric indications following original NDAs rose sharply, increasing 107% between 1998 and 2009. The number of NDA new indications increased 15%, and the number of supplemental NDA new indications declined 5% during this period. Anti-infective and CNS drugs each accounted for one-fifth of all new or modified indication approvals between 1998 and 2009. Cardiovascular and oncology drugs accounted for 15% and 13% of all new or modified indications respectively. Moving forward, with finite resources, sponsors must strike the right balance in maximizing portfolio value by allocating R&D resources between novel, original NDAs, and new or modified indication approvals.

—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.