FDA issues 2 guidances to advance development of new therapies
In an effort to modernize clinical trials and advance the development of safe and effective drugs and biologics, the Food and Drug Administration on Monday released two guidance documents to assist drug companies that are developing these next generation of therapies and treatments.
The FDA’s draft guidance entitled, “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment,” is aimed at sponsors planning to use minimal residual disease, or MRD, as a biomarker in clinical trials of drugs or biologics to treat specific blood cancers.
“MRD as a general measure of tumor burden has multiple potential regulatory and clinical uses as a biomarker to help with more informed drug development,” FDA commissioner Scott Gottlieb said in a statement. “Depending upon the clinical setting, MRD may reflect a patient’s response to treatment, or it may be used as a prognostic tool to assess the risk of future relapse.”
The FDA also issued a final guidance, “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease,” which was issued as draft guidance in December 2017. The guidance addresses the topic of finding treatments that address the underlying molecular changes, e.g., genetic variants, that often cause or contribute to diseases, including uncommon or rare molecular changes that are present in a small subset of patients.
“By providing clarity on the regulatory and scientific frameworks for product developers, safe and effective targeted treatments can be identified with scientifically valid tests and, ultimately, made available to patients more efficiently,” Gottlieb said.
CVS Health reminds consumers to safely dispose unused medications
CVS Health is urging patients to clean out their medicine cabinets and safely dispose of unused prescription medication on National Prescription Drug Take Back Day on Oct. 27.
CVS Health has installed safe medication disposal units in more than 750 CVS Pharmacy locations nationwide and has donated more than 900 additional units to such community locations as police departments.
These units have collected more than 217 metric tons, or 480,000 pounds, of unwanted medication. Additionally, on Oct. 27, nearly 100 CVS Pharmacy locations will join other community sites around the country to host law enforcement take-back events, allowing the public to safely dispose of unwanted medication. National Prescription Drug Take Back Day is hosted biannually by the U.S. Drug Enforcement Administration, or DEA, to provide an opportunity for Americans to help prevent drug addiction and overdose deaths.
“CVS Health is dedicated to helping address and prevent prescription drug abuse and misuse, which is why we have worked to increase access to and awareness of safe medication disposal options in the communities we serve,” CVS Pharmacy vice president of professional services Tom Davis said in a statement. “Unused medications, especially opioids, should not be left in medicine cabinets where they could be at risk of misuse or diversion. We are proud to have supported the collection of more than 480,000 pounds of unwanted medication to date, getting it out of homes and disposed of safely, and we are looking forward to adding to that achievement.”
According to the 2016 National Survey on Drug Use and Health, 6.2 million Americans misused controlled prescriptions and often obtained them from family and friends. In-home medicine cabinets are often the source of diverted prescriptions, making it critical for patients to properly dispose of unused prescriptions in a timely manner to prevent prescription misuse and diversion.
Dr. Reddy’s gets FDA nod for generic Aggrenox
Dr. Reddy’s Laboratories has received the okay from the Food and Drug Administration for aspirin and extended-release dipyridamole capsules.
The product is a generic version of Boehringer Ingelheim’s Aggrenox (aspirin and extended-release dipyridamole) capsules.
Aggrenox is indicated for the prevention of stroke following an initial first stroke, or transient ischaemic attacks (TIA).
The Aggrenox brand and generic had a market value of approximately $183 million for the most recent 12 months ending in August 2018, according to IQVIA data.
Dr. Reddy’s aspirin and extended-release dipyridamole capsules is available in 25 mg/200 mg strength with a 60 count bottle size.