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Pfizer's leukemia drug, 4 others recommended for EU approval


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Essential IR Insights Newsletter - February 2023

Pfizer's leukemia drug, 4 others recommended for EU approval

The European Medicines Agency recommended the approval of five new therapies this month, including Pfizer Inc.'s blood cancer drug Mylotarg for patients aged 15 years and above.

Mylotarg, which is designated as an orphan drug by the European regulator, is already approved as a treatment of acute myeloid leukemia in the U.S.

The EMA also recommended another orphan drug for approval: privately held Ammtek's Amglidia for the treatment of neonatal diabetes mellitus in children, including newborns.

Meanwhile, BioCryst Pharmaceuticals Inc.'s UK subsidiary received an approval recommendation for its drug Alpivab to treat uncomplicated influenza.

Two Chiesi Farmaceutici S.p.A. drugs, Trydonis and CHF 5993, also received the EMA's backing. The so-called maintenance therapies are aimed at adults with moderate to severe chronic obstructive pulmonary disease, which affects the lungs.

Meanwhile, the EMA rejected Puma Biotechnology Inc.'s breast cancer drug Nerlynx, noting that the medicine's benefits did not outweigh its risks. The European regulator also denied Pfizer's request for an expanded approval of Sutent to include treatment of patients who are at a high risk of kidney cancer returning following surgery.

Moving ahead, the EMA recommended an extension in the therapeutic indication of six medicines including Pfizer's Bosulif to allow its use in adult patients who are newly diagnosed with a type of chronic myeloid leukemia.

Bosulif is currently approved for patients who have already been treated with one or more existing medicines and for those who have limited treatment options.

Similarly, Shield TX (UK) Ltd.'s Feraccru was recommended as a treatment option for iron deficiency in adults. The drug is currently only approved for iron deficiency anemia patients with inflammatory bowel disease.

Other medicines which were recommended for an extension in their therapeutic indication were Merck & Co. Inc.'s HIV drug Isentress; Amgen Inc.'s Xgeva; AstraZeneca PLC's ovarian cancer drug Lynparza; and Swedish Orphan Biovitrum AB's Kineret.

Elsewhere, Gilead Sciences Inc. withdrew its application to extend the use of its blood cancer medicine Zydelig after the EMA's Committee for Medicinal Products for Human Use determined that the company did not provide sufficient data to demonstrate that the drug's benefits outweighed its risks.