How much will this drug make? The clinical differentiation isn't that great and the drug seems to be less safe. What value will it have the sensipar is generic? The clinical differentiation isn't strong enough. "To try and persuade payers that it is worth it, Amgen completed a head-to-head study against Sensipar last year. The 683-patient trial met its primary endpoint on non-inferiority. 68% of patients receiving Parsabiv achieved a greater than 30% reduction from baseline in mean parathyroid hormone levels compared with 58% using Sensipar. It also demonstrated superiority with 52% achieving greater than 50% reduction versus 40% of patients on Sensipar. While Parsabiv differentiated on efficacy its safety profile will be watched closely. There was an increased rate of cardiac failures with Parsabiv compared with Sensipar at 3.0% and 0.6%, respectively. Also fatal events were seen in 2.7% of Parsabiv and 1.8% of Sensipar patients." IV Sensipar = more cardiac events and more fatal events. When this shit is generic....IV sensipar is done! AMGEN LOSES AGAIN PEOPLE
Basically a 10% gain in efficacy endpoints leads to a 5X or 500% relative increase in cardiac events and a 50% relative increase in total fatal events. Clinically, it doesn't sound like a winner. And higher cost with safety issues will stall the launch until experience. But in two years after a slow launch, sensipar will be generic. This drug has limited potential.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 24, 2016, for the etelcalcetide application. Yet we hear nothing from the FDA?
I am waiting for the FDA rejection so INBU reps can cry some more. Keep pushing Enbrel! Former Kyprolis Rep at a real company again
It's 5:30pm EST and no decision. Means FDA sees safety as an issue with this drug. It's not like we don't already have sensipar.
This mean no approval and the FDA has concerns! THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response. The Complete Response Letter does not impact our regulatory submissions in other regions.
Sec. 314.110 Complete response letter to the applicant. (a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in 314.125 or 314.127, respectively. (1) Description of specific deficiencies. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section. (2) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed. (3) Inadequate data. If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling. (4) Recommendation of actions for approval. When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval. (b) Applicant actions. After receiving a complete response letter, the applicant must take one of following actions: (1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter. (i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission. (ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission. (iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission. (iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission. (v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission. (2) Withdrawal. Withdraw the application or abbreviated application. A decision to withdraw an application or abbreviated application is without prejudice to a subsequent submission. (3) Request opportunity for hearing. Ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively. The applicant must submit the request to the Associate Director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Within 60 days of the date of the request for an opportunity for a hearing, or within a different time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under 314.105, or refuse to approve the application under 314.125 or abbreviated application under 314.127 and give the applicant written notice of an opportunity for a hearing under 314.200 and section 505(c)(1)(B) or (j)(5)(c) of the act on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively. (c) Failure to take action. (1) An applicant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated application, FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application. (2) If FDA considers an applicant's failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn. [73 FR 39609, July 10, 2008]
Amgen has 2 years to make money off this outside the bundle. If it takes another 9 months to launch (3 months to discuss with FDA + 3 months to submit new data + 3 months for new FDA review) then the product will have only 16 months until the drug is in the bundle. That isn't enough time to build physician experience and loyalty so that they are not financially incentivized to use generic sensipar.
Not good. Since 2012, under the enhanced PDUFA V, 71.9% of drugs have been approved during the first review cycle. Someone in the front office royally screwed up.
On the company’s first quarter call they noted that the Centers for Medicare and Medicaid Services (CMS) have given a two-year period where Parsabiv will operate outside the bundle under the average sales price. This will give the CMS time to decide the value of the bundle once the product is included. Sensipar, an oral drug, lies outside the scheme and loses patent protection in 2018 (March 8, 2018), so generic Sensipar could present a challenge to the profitability of Parsabiv. If this launches let's say next March, then Amgen will have 1 year until Sensipar is generic.
In the head-to-head study, Sensipar and Parsabiv looked similar, with Parsabiv showing higher rates of treatment-emergent AEs (93% vs. 90%) overall, with a slightly lower rate of serious adverse events (25% vs. 27%). Specifically, Parsabiv showed higher incidence of hypocalcemia (5% vs. 2.3%), cardiac failure (3% vs. 0.6%), and fatal adverse events (2.7% vs. 1.8%). It remains unclear whether or not these differences factored into the FDA’s decision. It is possible that the modest increase in these adverse events outweighed the benefits provided on secondary endpoints and in the differing administration, in the FDA’s opinion. It’s also possible that this is just a minor CMC issue and can be quickly resolved.
Amgen's Shameful Silence Covers Up Reasons for FDA Drug Rejection An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. regulators Wednesday but the biotech company offered no public explanation for why the drug's marketing application was denied. Amgen's decision to offer no information at all about Parsabiv's rejection is a shameful shirking of its responsibility to be transparent with investors.
https://www.thestreet.com/story/13685275/1/amgen-s-shameful-silence-covers-up-reasons-for-fda-drug-rejection.html?puc=yahoo&cm_ven=YAHOO This is Amgen great place to be!!! Transparency is what they say they give us, but banker bob only does what's best for his stock and sharing bad news is not in his best interest.
Piper Jaffray's Joshua Schimmer noted that, while Parsabiv beat Sensipar in secondary PTH endpoints in the head-to-head phase III trial, researchers also found a higher rate of side effects such as hypocalcemia, plus an "unfavorable imbalance in treatment-related adverse events related to heart failure and treatment related mortality." Two trials vs. placebo showed superiority in PTH reduction while not turning up the mortality or heart failure imbalances, "which is not surprising, considering the mechanism" of action, he wrote. "In the absence of an obvious explanation for the CRL (if it were a simple non-clinical issue, we suspect that would have been communicated to the company), our base assumption is that it is safety related," and it's "unclear if the other agencies will have similar concerns."
