Portola navigates manufacturing woes to gain US approval

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Moussa81)
(Image: Getty/Moussa81)

Related tags: Portola Pharmaceuticals, Andexxa, Xarelto, Eliquis

The company’s anticoagulant reversal treatment received a complete response letter from the FDA in 2016 but will be made available today after its approval.

The company’s anticoagulant reversal treatment received a complete response letter from the FDA in 2016 but will be made available today after US FDA approval.

Portola Pharmaceuticals announced on the last day of 2018 that the US Food and Drug Administration (FDA) had approved its ‘prior approval supplement’ application for commercial launch of Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo).

The drug is indicated for use when Xarelto (rivaroxaban) or Eliquis (apixaban), both anticoagulants, result in life-threatening or uncontrolled bleeding.

The ‘generation 1’ version of the treatment had previously received a complete response letter​ by the FDA over requirements for additional data to be provided regarding its chemistry, manufacturing, and controls.

However, the San Francisco-based company was able to reach patients through an ‘Early Supply Program’, which saw a limited number of healthcare providers given access to ‘generation 2’ Andexxa.

“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,”​ said Scott Garland, Portola’s CEO.

Garland announced today that commercial supplies would be made available in the US, speaking at the J.P. Morgan Healthcare Conference.

He added that the company is awaiting a decision by the European Medicines Agency’s Committee for Medicinal Products for Human Use, with a response expected at the end of February.

Prior to approval, the company plans to initially commercialise the treatment in the UK, Germany, Netherlands and the Nordic countries – due to the likelihood of reimbursement, Garland explained.

Bright future

Garland explained that the treatment will likely see increased use in the years to come, as the company has identified a 20% growth rate, year-on-year, of bleeding events in the US.

He further noted that once patents on Xarelto and Eliquis expire, 2021 and 2023, respectively, this should also see the sales of Andexxa, which is used in conjunction, rise due to the increased availability of the treatments.

Related topics: Regulatory & Safety, Regulations, QA/QC

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