Rising Proportion of New and Modified Indication Approvals
Applied Clinical Trials
Tufts Center for Drug Development
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.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
September 5th 2024Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.
