April 4 RxAdvocate April, 2024 — Newsletter
April Stories:
- FDA Approves New Drug for the Treatment of NASH
- FDA Approves First Interchangeable Biosimilars to Prolia and Xgeva
- April Recognizes National Infertility Awareness Week
- Easter Weekend and Family Time
New Drug Approval for the Treatment of NASH
The Food and Drug Administration (FDA) granted accelerated drug approval for Rezdiffra, which marks the first therapy approved for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH). NASH is a condition marked by fat buildups in the liver, which contribute to inflammation and damage to the liver. It is estimated that 1.5-6.5% of adults in the United States have NASH.
Prior to this first in class drug approval, the recommendations for NASH treatment were lifestyle modifications such as following a wholesome diet and maintaining a healthy weight. FDA’s approval for Rezdiffra was based on 12 months of data showing an improvement of liver scarring and maintenance or improvement in NASH compared to placebo plus diet and exercise modifications. Rezdiffra was approved through an accelerated approval process and will release final study results upon completion of an ongoing 54 week study.
The FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to Xgeva (denosumab) to treat certain types of osteoporosis and prevent bone events in cancer respectively. Both Jubbonti and Wyost are administered by subcutaneous injection and may be taken along with calcium and vitamin D as necessary to treat or prevent low calcium levels.
The approval of these biosimilars with interchangeability designations allows them to be substituted for their respective reference product at the pharmacy level without needing to wait for a provider to give permission to do so.
Due to ongoing litigation between Sandoz, the manufacturer of the biosimilars and Amgen, the producer of the reference products, there is currently no launch dates or pricing information available.
According to the manufacturer Sandoz, over 10 million adults over age 50 in the US have osteoporosis, of whom most (> 80%) are women. It is predicted that 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture in their lifetime, which could result in decreased quality of life, disability, and death.
April Recognizes National Infertility Awareness Week
April 21st-27th is National Infertility Awareness week. Infertility is described as not being able to become pregnant after a year or longer. In the United States, infertility can be a common problem among women aged 15-49 years old with no prior births but less common among women with one or more prior births. Both men and women can contribute to infertility.
For men, infertility can be caused by different factors such as disruption of testicular or ejaculatory function, hormonal disorders, and genetic disorders. For women, conditions such as Polycystic ovary syndrome, Menopause or any conditions affecting the ovaries, fallopian tubes or the uterus can contribute to infertility.
Factors such as smoking, increased alcohol use, absent periods, obesity, and age can also play a role in the risk of infertility.
You can wear orange on April 24th to show support to Infertility Awareness.
Easter Weekend and Family Time!
Contact us
Orlando.Neal@rxconnectionllc.com