Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications for a candidate or applications for updating product information, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Pharmacyclics, Inc. PCYC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended full approval of Imbruvica.
The CHMP recommended a change in the terms of the marketing authorization for Imbruvica in Europe to indicate the treatment of adult patients with Waldenström's macroglobulinemia (WM) who underwent at least one prior therapy, or as the first-line treatment for patients unsuitable for chemo-immunotherapy.
We note that the drug is already approved in Europe for the treatment of adult patients suffering from relapsed or refractory mantle-cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who received at least one prior therapy.
We remind investors that Imbruvica gained full FDA approval for all lines of therapy for the treatment of patients suffering from WM in Jan 2015.
The drug is also approved for accelerated approval in the U.S. for the treatment of patients with MCL who have received at least one prior therapy. Continued approval for this indication is contingent on verification of clinical benefit in confirmatory trials.
The EMA generally takes the CHMP’s opinion into account while reviewing candidates. A final decision from the committee is expected in the second half of 2015.
Imbruvica is Pharmacyclics’ sole marketed product. Hence, a label expansion and approval in additional geographies will boost growth prospects of the drug significantly. Pharmacyclics has a collaboration agreement with Janssen, a Johnson & Johnson JNJ company, for Imbruvica.
Pharmacyclics holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care space include Valeant Pharmaceuticals VRX and Gilead Sciences GILD. Both carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment