Jacobus Pharmaceutical has priced its medication at $80 per pill, less than half the price of a similar pill sold by its rival, Catalyst Pharmaceuticals, according to STAT.
Six things to know:
1. Jacobus in May won FDA approval for its rare disease drug, Ruzurgi, a treatment for Lambert-Eaton myasthenic syndrome in children ages 6 to 17. The disorder affects the connection between nerves and muscles, causing weakness in affected patients.
2. The FDA approval of Jacobus' drug added potentially unforeseen competition to Catalyst's $375,000 drug for LES in adults, Firdapse, which was at the center of a pricing controversy earlier this year.
3. Although the two drugs are for different age ranges, providers may be able to prescribe Ruzurgi as an off-label drug to treat adult patients, competing with Firdapse.
4. Catalyst charges $171.23 for each tablet.
5. Edward Nash, a senior biotechnology analyst for SunTrust Robinson Humphrey, wrote in an investors' note cited by news website STAT, that "Physicians are unlikely to prescribe and payers are unlikely to reimburse" the Jacobus drug because it is only approved for children. However, a physician told STAT that there is nothing unusual about prescribing off-label drugs to patients, which happens often..
6. The controversy surrounding Firdapse, a formerly inexpensive drug, began in December when Catalyst hiked the price of it to $375,000 a year after the FDA approved it. Patients had formerly received the drug, used off-label to treat the rare disease, for free from Jacobus Pharmaceuticals. In February Sen. Bernie Sanders, I-Vt., called the pricing decision "a blatant fleecing of American taxpayers" and an "immoral exploitation of patients."