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.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
