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Full commercial launch of the drug is underway in the United States, with Europe to follow.
On Jan. 24, 2019, Lonza announced the start of commercial supply for Portola Pharmaceuticals’ second-generation Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), a hemophilia drug that is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This move follows the Dec. 31, 2018 approval by FDA of Portoloa’s prior approval supplement for large-scale production of the drug.
Commercial production is being carried out at Lonza Pharma & Biotech’s Porriño, Spain, facility, which houses 10,000 L of mammalian production capacity. This will be supplemented by additional large-scale capacity in Ibex Dedicate at Lonza’s Visp, Switzerland, site when that unit comes on line in 2020. The two sites are expected to ensure flexible supply.
An opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use is expected to be given on Feb. 28, 2019.
Lonza worked closely with Portola to develop the second-generation manufacturing process for Andexxa. “Our teams have taken up the challenge with Portola by combining our expertise to ensure their product can reach the patients who need it,” said Sylke Hassel, head of
commercial mammalian and microbial manufacturing at Lonza Pharma & Biotech, in a company press release.