Teva’s Synribo completes post-marketing commitment
Teva’s Synribo, a chronic myeloid leukemia (CML) treatment has been given final US approval after the company fulfilled a post-marketing commitment.
The drug was approved by the FDA in October 2012, but required a period of strict post-marketing safety monitoring because of the severe and potentially fatal side effects of the chemotherapy.
The injectable Synribo (omacetaxine mepesuccinate) is indicated for adult patients with chronic phase or accelerated phase CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
The drug causes myelosuppression, bleeding caused by severe thrombocytopenia, and can also cause hyperglycemia, and in pregnant women, embryo-foetal toxicity.
This severe toxicity profile means that the drug is reserved for those patients who have stopped responding to drugs such as Novartis’ Glivec(imatinib) and Tasigna (nilotib) and BMS’s Sprycel (dasatinib).
“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of Synribo, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, president and chief executive, Global Specialty Medicines. “This approval reinforces our ongoing commitment to providing Synribo to people living with CML who have failed two or more TKI therapies.”
Teva is facing tough times, and faces generic competition to its flagship branded drug Copaxone, which are likely to gain approval in 2014 or 2015.
The company is the world’s biggest producer of generic drugs, but also develops its own patent-protected medicines.
The company appointed a new chief executive, Erez Vigodman, in January after Jeremy Levin stepped down in October following a boardroom row over the firm’s strategic direction.
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