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FDA Breakthrough Therapy Designation: Fifth Drug Receives FDA Approval

April 18, 2014

The FDA approves on April 17th, GlaxoSmithKline’s orphan drug Arzerra (Ofatumumab injection for intravenous infusion), the 5th drug to have the coveted Breakthrough Therapy Designation (BTD). A Supplemental Biologic License Application (sBLA) for Arzerra receives approval for use in combination with Chlorambucil, for the treatment of previously untreated patients with Chronic Lymphocytic Leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The BTD is for the same indication.

Arzerra is currently marketed in the United States and is granted FDA Accelerated approval in 2009 for CLL refractory to Fludarabine and Alemtuzumab (Campath). As a condition of the 2009 approval, GlaxoSmithKline is required to have further studies. Per the FDA, the trial used for the basis of the April 17th approval fulfilled that 2009 postmarketing requirement, and accelerated approval is converted to regular approval :

FDA Orphan Drug Database Record
Generic Name: Ofatumumab
Trade Name: Arzerra
Date Designated: 03-10-2009
Orphan Designation: Treatment of chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
FDA Orphan Approval Status: Approved for Orphan Indication
Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine
Marketing Approval Date: 10-26-2009
Exclusivity End Date: 10-26-2016
Approved Labeled Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Marketing Approval Date: 04-17-2014
Exclusivity End Date: N\A
Sponsor: GlaxoSmithKline One Franklin Plaza Philadelphia, PA 19101 The sponsor address listed is the last reported by the sponsor to OOPD.

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Of the 5 BTD approvals, 3 are for the CLL indication:

Row Num Drug Name FDA Approval Date Sponsor Company Indication
1 Gazyva   (Obinutuzumab) 11.01.13 Genentech Chronic Lymphocytic Leukemia (CLL)
2 Imbruvica   (Ibrutinib) 02.12.14 Pharmacyclics Chronic Lymphocytic Leukemia (CLL)
3 Ofatumumab (Arzerra) 04.17.14 GlaxoSmithKline In combination with Chlorambucil for previously untreated Patients with CLL for whom fludarabine-based therapy is considered inappropriate

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “DNA Purification” Courtesy of Dr. Bruce Chassey Laboratory. National Institute Of Dental Research. Li-shan. NCI [Public domain in the US].

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