The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated. Here’s a look at two more FDA decisions coming up this week.
The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated, although the agency approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) for phenylketonuria (PKU) just before the holiday. PKU is a rare genetic disease, observed at birth and can cause seizures and neurological and neuropsychiatric problems. The company expects to launch the drug commercially in the U.S. by the end of June. It is also being evaluated by the European Medicines Agency.
And although it had a PDUFA action date of Monday, May 28 (Memorial Day in the U.S.), the agency approved Amgen’s supplemental BLA (sBLA) for Prolia (denosumab) to treat patients with glucocorticoid-induced osteoporosis (GIOP) a week early, on Monday, May 21. This was the fifth indication approved for Prolia, which was originally approved in 2010 for osteoporosis.
Here’s a look at two more FDA decisions coming up this week.
1.TherapeuticsMD. Headquartered in Boca Raton, Florida, TherapeuticsMD is expecting a decision on its resubmission of its New Drug Application (NDA) for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule to treat moderate-to-severe vaginal pain during sex (dyspareunia) due to menopause. The PDUFA date is Tuesday, May 29. The resubmission is a complete, class 2 response to a Complete Response Letter (CRL) the company received on May 5, 2017. The company submitted additional endometrial safety information on September 14, 2017, outside of an official review cycle. If approved, the company hopes to launch the drug in the third quarter of this year.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” said Robert Finizio, the company’s chief executive officer, in a statement in December 2017. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.” VVA is vulvar and vaginal atrophy.
2. Kitov Pharmaceuticals. Kitov, based in Tel Aviv, Israel, expects the FDA to approve its KIT-302 by May 31. The NDA was filed in October 2017. KIT-302 is a patented combination of celecoxib and amlopidine to treat osteoarthritis pain and hypertension simultaneously. If approved, the drug will be marketed under the brand name Consensi.
Both components of the drug are FDA approved. Pfizer’s Celebrex (celecoxib) is a COX-2 inhibitor to treat osteoarthritis. Pfizer’s Norvasc (amlodipine besylate) is a calcium channel blocker for lowering blood pressure.
“The acceptance of filing of our NDA for KIT-302 represents a key achievement toward commercialization of our lead drug candidates,” said J. Paul Waymack, the company’s chairman and chief medical officer, in a 2017 statement. “We intend to work closely with FDA as it reviews the NDA. We look forward to FDA rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018.”
