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Latest From Ian Schofield
Restrictions placed on the use of Gedeon Richter’s uterine fibroid drug Esmya by the European Medicines Agency could significantly dent the product’s sales in the EU, and could also have a knock-on effect in the US, where the FDA accepted an NDA filing for the drug in October 2017.
EU safety restrictions relating to liver toxicity concerns are likely to lead to changes to the labeling of Richter’s uterine fibroid product Esmya and to a sharp drop in the product’s sales. The moves could also affect the product in the US, where it was filed for approval last year.
Companies looking forward to a ruling from the Supreme Court on “plausibility” in the UK case involving second medical use patents may have to wait until May or June.
An advocate general of the Court of Justice of the EU has given an opinion in the case of Pfizer v Orifarm that, if followed by the full court, will clarify the scope of the “specific mechanism” that was introduced to give patent holders protection against parallel imports from the acceding member states between 2004 and 2013.
UK health secretary Jeremy Hunt has been told by the Commons health committee that the government must agree a Brexit transition period that preserves the “regulatory status quo,” otherwise companies will be forced to start spending money on contingency planning that may prove unnecessary.
New products submitted for evaluation by the European Medicines Agency include Pfizer’s lorlatinib for lung cancer, Teva’s fremanezumab for migraine, and Shionogi’s lusutrombopag for thrombocytopenia. An already authorized drug, Novartis’s canakinumab, has been filed for a new use: reduction of cardiovascular risk.