FDA Approves New Treatments & Makes Birth Control Pills Available OTC
FDA Approves New Treatments & Makes Birth Control Pills Available OTC
Three Things Thursday
Three Things Thursday highlights three things I am paying attention to as an epidemiologist each week.
The three things that I am paying attention to this week all have to do with the FDA. FDA has been busy reviewing, discussing, and approving new drugs this summer. There is a new drug to treat Alzheimer’s disease, monoclonal antibodies to fight RSV in young children (including newborns), and an over-the-counter birth control pill.
These are exciting and important developments!
Hoping this post helps to educate and empower you
to be healthy and create healthy communities.
Approval of a Drug to Treat Alzheimer’s Disease
Alzheimer’s disease is the most common form of dementia — it is a progressive disease. The disease begins with memory loss and progresses to the point where an individual is unable to have a conversation or care for themselves. The parts of the brain that control thought, memory, and language are impacted by the disease. In 2020, upwards of 5.8 million Americans were living with Alzheimer’s, and that number is expected to triple by 2060.
Earlier this month, the FDA granted full approval to the first therapy/drug that is designed to slow the cognitive decline associated with Alzheimer’s disease.
The drug — LEQEMBI® — works by reducing plaques that form in the brain and is administered as an infusion. According to Bloomberg News, the new drug has to be administered once every couple of weeks and requires a team of medical professionals (genetic counselors to nuclear medicine specialists) to determine if a patient is eligible for the drug and to monitor for adverse effects of the treatment. LEQEMBI® will cost about $26,500 per year. BUT it will be covered by Medicaid and Medicare.
NOTE — Alzheimer’s disease is terminal. And the adverse effects of the disease are awful. Given this, medical and pharmaceutical professionals are willing to accept more/greater risks from treatment. The risks associated with this Alzheimer’s drug are significant and as you’ll read below the outcome of the drug is fine (definitely not amazing). But it brings hope (for the first time to individuals diagnosed with the disease and provides some slowing of the disease, buying time). This drug is far from perfect and somewhat controversial because of all the potential adverse effects. It is a step forward in treatment. It is a far cry from a cure.
Clinical trial results showed that LEQEMBI® slowed the rate of cognitive decline in Alzheimer’s patients by 27% compared to a placebo/untreated group. Dr. Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research stated following the full approval of the drug —
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
LEQEMBI® will likely be available to a limited number of patients at large medical institutions (Hopkins, Mayo Clinic) in the fall.
In addition to LEQEMBI®, on Tuesday results from a study focused on another new Alzheimer’s disease drug — Donanemab made by Eli Lilly — showed that this new drug slowed the progression of the disease by 35%. In addition to being published in JAMA, the results of the study were submitted to FDA, and we are expecting a decision regarding the approval of Donanemab before the end of 2023.
Please note — while this is exciting news for those suffering from Alzheimer’s disease, neither of the new drugs is a cure. The benefits of both are a delay in the onset of loss of memory and thinking. The delay is estimated to be between 7 months and 1 year.
This is a huge step forward in the treatment of this deadly disease.
Approval of Monoclonal Antibodies for RSV for Young Kids
On Tuesday, FDA approved AstraZeneca’s Beyfortus — for the prevention of Respiratory Syncytial Virus (RSV). Specifically, Beyfortus is designed to prevent severe illness caused by RSV in newborns and toddlers. The drug was approved by FDA for newborns and babies entering their first RSV season and for children (up to 24 months) who are at risk of severe disease in their second RSV season.
Each year 58,000-80,000 children younger than 5 years old are hospitalized with RSV. And between 100-500 die each year from RSV.
Beyfortus aims to reduce these numbers and protect our youngest children.
I was on Erie News Now talking about this. Watch the clip —
CDC still needs to approve the Beyfortus for use. CDC is expected to meet in August to discuss and approve Beyfortus’s use. More to come…
Approval of Over-The-Counter Birth Control Pills
Late last week, FDA approved the first over-the-counter (OTC) birth control pill. Individuals will now be able to purchase birth control online or at pharmacies or grocery stores without a prescription.
The over-the-counter pill — called Opill — is expected to be available in early 2024.
At this point in time, it is now clear how much Opill will cost. Stay tuned… rumors are swirling that it could cost upwards of $20 per month, which will limit Opill’s use by individuals living in poverty or on a fixed budget (who desperately need access to free birth control).
You might be wondering — why is this such a big deal (it is!)?!?!
According to The Center for American Progress —
“Birth control is a vital and essential public health service. Access to contraception and high-quality contraceptive care has wide-ranging and far-reaching implications for women’s rights and advancement as well as the potential to improve women’s quality of life… A plethora of research demonstrates that, with improved access to contraception, women have greater educational attainment, increased workforce participation, and higher incomes.”
And according to The Century Foundation —
“Birth control use is overwhelmingly common: in 2018, 65 percent of U.S. women of reproductive age were using a contraceptive method, and 99 percent of women use at least one method during their lifetime.”
Many individuals using the birth control pill before it was available OTC were unable to get timely appointments to be their prescriptions renewed. Specifically, upwards of one-third of birth control users report missing a dose (which could lead to an unintended/unwanted pregnancy) because they could not get to the doctor in time.
Access to birth control, especially the pill, NEEDS to be non-discriminatory, equity-driven, and coercion-free. AND the pill needs to be easily accessible.
Allowing the birth control pill to be purchased OTC will increase access to this common form of birth control. The American Medical Association applauded FDA’s approval by stating that it was —
“a monumental step in providing broader access to safe and effective reproductive health care… (and) that removing the ‘barriers’ to accessing contraception will empower more Americans to make their own family-planning decisions…”
More to come in the coming months as hear more from the manufacturer about availability and pricing…
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