Editors' (re)View: Weight loss at a cost; Birth control makes moves

July 14, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 10

Weight loss at a cost

The Ozempic fascination has taken the world by storm.  At this year’s 95th Annual Academy Awards, even host Jimmy Kimmel couldn't escape the Ozempic obsession, joking, "Everybody looks so great. When I look around this room, I can't help but wonder 'Is Ozempic right for me?'

Beyond celebrities, Novo Nordisk's drug, which belongs to the GLP-1 class of drugs, has seen an all-time rise in prescriptions this year. According to analyses by J.P. Morgan of IQVIA data, Ozempic prescriptions in the U.S. peaked in the final week of February, with over 373,000 prescriptions filled. 

With its rise in popularity, regulators are now paying closer attention to the effects it has on patients. This week, we reported that the EMA will conduct a review of the popular diabetes medication to assess the potential risks of suicidal thoughts and self-harming behavior. 

Following two incidents involving patients in Iceland, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) announced its intention to investigate these adverse events and determine if they are linked to the drug. Additionally, the PRAC will examine all drugs belonging to the GLP-1 class, including Novo Nordisk's Saxenda (liraglutide) and Wegovy (semaglutide).

The high demand for Ozempic, along with manufacturing challenges related to a CDMO, has resulted in a shortage of both Novo Nordisk's semaglutides — Ozempic and the version specifically approved for weight loss, Wegovy.

Ozempic is already comes with potential side effects, namely thyroid cancer and gastrointestinal adverse events.

With ongoing investigations and existing associations with various medical conditions, the extent of Ozempic's impact on patients has yet to be fully understood. 

— Andrea Corona 

Birth control leaps over the counter

At long last, the U.S. FDA has given the green light to the first ever OTC birth control pill, and the U.S. joins over 100 countries already offering OTC oral contraceptives.

The historic leap over pharmacy counters went to Perrigo's Opill, a progestin-only daily oral contraceptive, now available for all ages.

CDER director Patrizia Cavazzoni pointed out that the approval will make Opill the most effective birth control method available over the counter. In clinical trials of norgestrel tablets, the perfect-use effectiveness of pills like Opill proved as high as 98%.

What shocked me the most when I authored a recent cover story about reproductive health drugs was the statistic on unplanned pregnancies in the U.S. For years, despite a plethora of safe and legal contraceptive options, the rate of unintended pregnancies in the U.S. has hovered just under 50%. For context, an estimated 3,661,220 children were born nationwide in 2022 — which nets out to a lot of accidental babies. 

While there are myriad factors that contribute to unplanned pregnancies, access to contraceptives is a significant issue. And included under the umbrella of accessibility is price. Perrigo has not yet revealed the price for Opill, only promising it will be ‘affordable’ — that detail will prove key to exactly how momentous this leap will be.

–Karen Langhauser