ARIAD Pharmaceuticals, Inc. (ARIA - Free Report) announced that the FDA has granted a full approval to its leukemia drug, Iclusig (ponatinib), following its successful completion of the commitments made on the receipt of accelerated approval in Dec 2012.
Iclusig is approved for the treatment of adult patients suffering from T315I-positive chronic myeloid leukemia (CML: chronic, accelerated or blast phase) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) or for whom no other TKI therapy is approved.
Over the last one month, ARIAD’s share price has surged 58.3% compared to the Zacks classified Drugs Market of 7.6%. We expect shares to gain higher following the latest approval.
Note that Iclusig, ARIAD’s only marketed drug, is approved in both the U.S. and the EU. The latest approval and label update was based on long-term safety and efficacy data from the pivotal phase II PACE clinical trial (n=449) on Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. Data from the PACE study showed that a minimum follow-up of 48 months with Iclusig led to sustained long-term cytogenetic and molecular responses in many chronic-phase CML patients.
The four-year follow-up data demonstrated the durability of the high response rates achieved with Iclusig in refractory CML patients for whom no other TKI therapy is appropriate, including those with the T315I mutation.
Notably, Iclusig was granted orphan drug designation by the FDA for the treatment of leukemia.
This September, Iclusig received Japanese approval for the treatment of CML and is being marketed by partner Otsuka.
Apart from the PACE study, ARIAD is conducting two other studies on Iclusig – the OPTIC dose-ranging study and the OPTIC-2L study for second-line chronic-phase CML.
Even though the CML market represents significant potential, Iclusig faces intense competition, as the market is crowded by Novartis AG’ (NVS - Free Report) Gleevec, Bristol-Myers Squibb Company’s (BMY - Free Report) Sprycel and Pfizer Inc.’s (PFE - Free Report) Bosulif among others. All the three drugs are approved for the treatment of CML in patients who are either resistant or intolerant to prior TKI therapies.
ARIAD currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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