EMA Suspends Picato Authorization, Confirms Limits for High-Strength Estradiol Creams

Regulatory NewsRegulatory News | 17 January 2020 |  By 

The European Medicines Agency (EMA) is following a recommendation from its Pharmacovigilance Risk Assessment Committee (PRAC) this week to suspend the marketing authorization for Leo Pharma’s actinic keratosis cream Picato (ingenol mebutate), while the agency investigates reports of increased rates of skin cancer associated with the drug.
The suspension follows PRAC’s investigation of Picato’s safety last year after multiple studies showed a higher rate of skin cancer cases in patients taking Picato compared to imiquimod, which is another drug used to treat actinic keratosis.
“While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer,” EMA writes.
Because there are alternative treatments on the market, EMA says patients should discontinue use of Picato until the agency completes its review of the drug and is able to make further recommendations. EMA also says that patients that have taken Picato should be vigilant about any “unusual skin changes or growths.”
EMA says it will be sending a direct communication to healthcare professionals later this month to inform them of its recommendations concerning Picato.
High-Strength Estradiol Creams
PRAC also reaffirmed its October 2019 recommendation to limit the use of high-strength estradiol creams containing 100 micrograms/gram (0.01%) of estradiol to a single four-week treatment duration to reduce the risk of developing elevated blood levels of the drug.
Estradiol creams are hormonal steroids used to treat vaginal atrophy symptoms in postmenopausal women. According to EMA, high-strength estradiol creams are authorized nationally in 10 EU member states under trade names Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff and Montadiol.
According to PRAC, “the absorption of estradiol into the bloodstream is of concern and could result in similar side effects to those seen with hormone replacement therapy (HRT),” which include the formation of blood clots, stroke, endometrial cancer and breast cancer. The committee adds that there is a limited long-term safety data for high-strength estradiol creams.
The committee reviewed its earlier decision in response to a request by a company that markets one of the products. Now that the recommendations have been confirmed they will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for implementation.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy