The FDA has announced the approval of the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with teriparatide injection (Forteo, Eli Lilly) as the reference drug. Like teriparatide injection, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

The manufacturer, Pfenex, is also petitioning the FDA to designate PF708 as therapeutically equivalent to teriparatide injection, which would permit PF708 to be automatically substituted for teriparatide injection in many states.

Pfenex is also conducting a comparative human factors study between PF708 and teriparatide injection as requested by the FDA. The final study report is anticipated to be submitted to the FDA as early as the second half of October 2019 and is believed to complete the information package required by the FDA to evaluate the therapeutic equivalence of PF708.

According to the National Osteoporosis Foundation, osteoporosis is a bone disease that occurs when the body loses too much bone, makes too little bone, or both. As a result, bones become weak and may break from a fall, or, in serious cases, from sneezing or minor bumps. The risk of having osteoporosis increases with age, with approximately 1 in 2 women and up to 1 in 4 men age 50 and older who will break a bone due to osteoporosis.2

“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market. To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating,” Eef Schimmelpennik, CEO of Pfenex, said in a statement.

Reference
  1. Pfenex Receives U.S. FDA Approval for PF708 to Treat Osteoporosis [press release]. PFEnex website. Published October 7, 2019. http://pfenex.investorroom.com/news-releases?item=157. Accessed October 8, 2019.
  2. What is Osteoporosis and What Causes It? National Osteoporosis Foundation website. https://www.nof.org/patients/what-is-osteoporosis/. Accessed October 8, 2019.