The 2015 Report of Progression of Modern Therapeutics provides graphs of new drug approvals for 40 therapeutic classes from 40 therapeutic categories. These include the 25 therapeutic classes that were in the 2014 Report, any updates on these, and 15 new ones, including irritable bowel syndrome, HIV-1/AIDS, hepatitis C, malaria, melanoma, pediatric acute lymphoblastic leukemia. Click here for the 2015 Report on this website.
As with most projects there are sometimes unexpected issues that come up from time to time, and this project is no different. We will comment on three such issues at this time:
Missing approved new drugs. Since the approach used for what new drug approvals to include involves a therapeutic class centered approach rather than an NME centered approach, it is possible there may be missing drug approvals, since these may involve secondary indications of NME’s or subsequent approvals of the same compound, and would thus not be included in FDA’s annual NME listings. Any such omissions will be corrected as appropriate.
Missing approval dates. For several older drugs, the exact initial approval date may not be listed in the Drugs@FDA database, or other readily available databases. In such cases, a footnote is added to that effect on the graphs for individual therapeutic classes, e.g., pediatric acute lymphoblastic leukemia and migraine; other examples would include tuberculosis.
Off-label use. For some diseases there is considerable off-label use, and a number of drug information websites may include such use, without necessarily distinguishing between FDA approved drugs and off-label use, e.g., migraine. Such examples of clinical use are typically not included on the graphs.
Random Observations and Comparisons
A perusal of this 2015 Report suggests a few lessons learned, including the following random observations and comparisons:
- Note significant recent advances in new drug approvals for hepatitis C, melanoma, cystic fibrosis, idiopathic pulmonary fibrosis, and irritable bowel syndrome, to name just a few.
- Note recent introductions of new pharmacologic classes or mechanisms of action for type-2 diabetes, dyslipidemia, multiple sclerosis, pulmonary arterial hypertension, and rheumatoid arthritis, to name just a few.
- Note no new introductions of new pharmacologic classes for depression (MAO inhibitors, tricyclics, SSRI’s/SNRI’s) and schizophrenia (typical and atypical antipsychotics) since the late 1980’s.
- Contrast melanoma with 8 new drug approvals since 2010 with childhood acute lymphocytic leukemia with most drugs from the 1950’s, 1960’s and 1970’s.
- Contrast plaque psoriasis with 7 new drug approvals with systemic lupus erythematous with 1 new drug approval since 2000.
- What do thrombolysis and acid reflux/gastric ulcer have in common? No new drug approvals since 2000/2001.
The two prior annual update reports (2013 Report and 2014 Report) contained different summary graphics, which are not included in the 2015 Report; these will be addressed in future posts.