Novartis ($NVS) scored EU approval for its multiple myeloma med Farydak (panobinostat), months after the FDA signed off on the drug for patients with serious forms of the disease. The approval provides another stepping stone for the med as Novartis tries to gain market share for the med against some tough competition.
The EU approval covers Farydak in combination with Takeda's blockbuster Velcade and anti-inflammatory steroid dexamethasone in patients who have already undergone two treatments, including Velcade and an immunomodulatory agent (IMiD). Regulators based their decision on a study of 147 patients in a subgroup of a Phase III trial that found a Farydak/Velcade/steroid combo tacked on 7.8 months to patients' survival on average, compared to 4.7 months for Velcade and a steroid alone.
The approval is a feather in Novartis' cap as it continues to regain momentum for the drug after some regulatory hiccups. Last year, the FDA waved off a speedy review process for the drug in light of serious side effects such as blood disorders and hemorrhage. But in March, the agency did an about-face and approved the drug after rejecting the advice of its independent panel of experts. Regulators also saddled Farydak with a black-box warning, highlighting risks of severe and often fatal cardiac side effects.
With U.S. and EU approval for Farydak in tow, Novartis has more ammo against rivals in the multiple myeloma market, including Celgene's ($CELG) Pomalyst and Amgen's ($AMGN) Kyprolis. Analysts at Bank Vontobel peg global peak annual sales of Farydak at $250 million, Reuters reports. But at that level, it would come in third behind Pomalyst, which had 2014 sales of $679.7 million, and Kyprolis, which hit $306 million.
Farydak is also up against promising data from Kyprolis and Pomalyst. Amgen earlier this year revealed interim study results showing that patients taking Kyprolis and dexamethasone lived for a median of 18.7 months without their disease getting worse, almost double the 9.4 months that Velcade posted. Plus, Kyprolis doesn't come with Farydak's safety issues.
Still, Novartis' drug could have far-reaching benefits for the 84,000 individuals suffering from multiple myeloma in Europe, the company said in a statement, many of whom do not respond well to other treatments.
"With the approval of Farydak in the European Union, we hope to address critically important treatment needs faced by the multiple myeloma community--disease progression and treatment resistance," Bruno Strigini, president of Novartis Oncology, said in a statement. "This milestone, the approval of a first in its class treatment option for patients in need of new therapies, is the result of more than 13 years of dedicated research, which has helped us better understand the development of multiple myeloma."
- read Novartis' statement
- here's the Reuters story
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