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FDA AdCom Votes on Pfizer and Spectrum Drugs - What Next?
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Yesterday, a couple of drugs came up before FDA advisory panels for review – large cap pharma Pfizer, Inc.’s (PFE - Free Report) Chantix and biotech company Spectrum Pharmaceuticals, Inc.’s Qapzola.
Chantix & Qapzola under Review
Data on Pfizer’s smoking cessation product, Chantix, from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) study was reviewed by a joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee. The randomized, blinded, placebo-controlled study was conducted by Pfizer in collaboration with GlaxoSmithKline plc (GSK - Free Report) and was designed in consultation with the FDA and the European Medicines Agency (EMA). The safety and efficacy of all three currently approved smoking cessation therapies, including Chantix, was compared in this study in more than 8,000 smokers with and without a history of psychiatric disorders.
Pfizer is looking to get the Chantix label updated based on the safety and efficacy outcomes of EAGLES. The company has applied for the removal of the boxed warning in Chantix’s label while at the same time it has proposed that the Warnings and Precautions section in the label regarding serious neuropsychiatric events occurring in patients attempting to quit smoking should be retained and updated with EAGLES data. According to the company, such a warning would be enough to inform prescribers of the possibility of the occurrence of such events.
Meanwhile, Spectrum is looking to get Qapzola approved for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer (NMIBC).
How Did the Vote Go?
Pfizer got a favorable response with the advisory committees giving a majority vote in favor of removing the boxed warning regarding serious neuropsychiatric adverse events from the Chantix label.
However, Spectrum’s Qapzola did not fare so well with the FDA’s Oncologic Drugs Advisory Committee (ODAC) voting that Qapzola did not show substantial evidence of a treatment effect over placebo. Shares were down 8.2% on the news.
While the FDA is not required to do so, it usually follows the advice of its advisory panels. So, in Chantix’s case, the agency is likely to decide to remove the boxed warning from the label which should have a positive impact on scrips and product sales. Chantix brought in total sales of $671 million last year and $434 million in the first six months of 2016. Chantix’s (EU trade name: Champix) EU label has already been updated to include the EAGLES data. The black triangle symbol, which indicated that additional safety monitoring was required for Champix in the EU, was removed as well.
Meanwhile, as far as Spectrum is concerned, the vote did not really come as a surprise considering Qapzola failed to meet the primary endpoint in two phase III studies. A final decision from the FDA is expected on Dec 11, 2016, but right now it looks like chances for gaining approval are low. With Spectrum currently conducting a phase III study on Qapzola under the FDA’s Special Protocol Assessment (SPA) program, we think the agency will ask the company for additional data before granting final approval.
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FDA AdCom Votes on Pfizer and Spectrum Drugs - What Next?
Yesterday, a couple of drugs came up before FDA advisory panels for review – large cap pharma Pfizer, Inc.’s (PFE - Free Report) Chantix and biotech company Spectrum Pharmaceuticals, Inc.’s Qapzola.
Chantix & Qapzola under Review
Data on Pfizer’s smoking cessation product, Chantix, from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) study was reviewed by a joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee. The randomized, blinded, placebo-controlled study was conducted by Pfizer in collaboration with GlaxoSmithKline plc (GSK - Free Report) and was designed in consultation with the FDA and the European Medicines Agency (EMA). The safety and efficacy of all three currently approved smoking cessation therapies, including Chantix, was compared in this study in more than 8,000 smokers with and without a history of psychiatric disorders.
Pfizer is looking to get the Chantix label updated based on the safety and efficacy outcomes of EAGLES. The company has applied for the removal of the boxed warning in Chantix’s label while at the same time it has proposed that the Warnings and Precautions section in the label regarding serious neuropsychiatric events occurring in patients attempting to quit smoking should be retained and updated with EAGLES data. According to the company, such a warning would be enough to inform prescribers of the possibility of the occurrence of such events.
Meanwhile, Spectrum is looking to get Qapzola approved for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer (NMIBC).
How Did the Vote Go?
Pfizer got a favorable response with the advisory committees giving a majority vote in favor of removing the boxed warning regarding serious neuropsychiatric adverse events from the Chantix label.
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However, Spectrum’s Qapzola did not fare so well with the FDA’s Oncologic Drugs Advisory Committee (ODAC) voting that Qapzola did not show substantial evidence of a treatment effect over placebo. Shares were down 8.2% on the news.
Price
Price | Quote
What Next?
While the FDA is not required to do so, it usually follows the advice of its advisory panels. So, in Chantix’s case, the agency is likely to decide to remove the boxed warning from the label which should have a positive impact on scrips and product sales. Chantix brought in total sales of $671 million last year and $434 million in the first six months of 2016. Chantix’s (EU trade name: Champix) EU label has already been updated to include the EAGLES data. The black triangle symbol, which indicated that additional safety monitoring was required for Champix in the EU, was removed as well.
Meanwhile, as far as Spectrum is concerned, the vote did not really come as a surprise considering Qapzola failed to meet the primary endpoint in two phase III studies. A final decision from the FDA is expected on Dec 11, 2016, but right now it looks like chances for gaining approval are low. With Spectrum currently conducting a phase III study on Qapzola under the FDA’s Special Protocol Assessment (SPA) program, we think the agency will ask the company for additional data before granting final approval.
Both Pfizer and Spectrum are Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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