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As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
Pharming Group N.V., a Netherlands-based biotechnology company, announced on Jan. 21, 2020 that it received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for its lead product, ruconest, for the treatment of hereditary angioedema, a disorder that involves repeated episodes of severe swelling.
With the facility officially approved, Pharming will now be able to release the product that was manufactured at the facility during the approval process for commercialization in the European Union, a company press release said. As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
“As we continue to see increasing demand for ruconest in the treatment of hereditary angioedema, we are pleased to announce the approval of our new facility, which will enable us to significantly increase production capacity for supply to patients in the EU,” said Sijmen de Vries, CEO of Pharming, in the press release. “In addition, as a result of our recent re-acquisition of ruconest’s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients.”
According to the release, FDA is still reviewing the facility’s post-approval supplement for the distribution of ruconest in the United States. Approval for distribution in the US is slated for early 2020.