FDA News, Week of July 27th – Drug and Device Digest

FDA approved

Medrobotics Flex System (Medrobotics Corporation, Raynham,  MA – a Carnegie Mellon Unv. spinoff)

First robot-assisted surgical platform with a unique, flexible, robotic scope that precisely moves through the body’s natural twists and turns

medroboticsReg Pathway : 510 K ; has received EU CE mark.

Indication for use:  Transoral Procedures in the Mouth and Throat; for use in head and neck surgeries

Effectiveness : A flexible endoscopic system that enables surgeons to access and visualize hard-to-reach anatomical locations, the system extends the benefits of minimally invasive surgery — shorter hospital stays and recovery times — to a broader population of patients

ReShape™ Integrated Dual Balloon Systemn  (ReShape Medical, Inc., San Clemente, CA)

balloonReg Pathway : PMA

Indication for Use : Weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.


  • Feasibility Study : 30 subjects, ReShape Duo Balloon (Treatment Group) vs diet/ exercise  (Control Group). ReShape Duo Balloon treated subjects had a mean weight loss greater than that of the control subjects at every point of follow-up.
  •  Pivotal REDUCE Study: 300 obese subjects, ReShape plus a diet/exercise (Treatment) vs. endoscopic procedure plus a diet/exercise (Active Sham) . ReShape group had 13.0% greater Excess Weight Loss vs sham group and the Responder rate (% weight loss >25%) of 49%.  However, weight maintenance for 24 weeks after device removal in the Treatment Group was not met consistently.

 Safety: No unanticipated adverse device effects. Higher nausea, vomiting, and abdominal pain with ReShape. Most significant concern –  gastric ulcerations and gastric bleeding

Benefit/Risk :

  • Probable benefits of demonstration of moderate weight loss with the device and some weight lost maintenance in some subjects 24 weeks after the device was removed.
  • Most worrisome risk is the development of gastric ulcerations.
  • Limited options currently available. ReShape better than diet and; however,  substantially less effective than approved gastric banding or other surgical interventions.
  • ReShape has potential for moderate short-term weight loss with an acceptable safety profile for subjects with mild to moderate obesity who have failed other means for conservative weight loss.


PRALUENT (Alirocumab, Sanofi-Aventis Bridgewater, NJ and Regeneron Pharmaceuticals Inc., Tarrytown, NY)

Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). To be administered subcutaneously once every 2 weeks

 Indication : indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.


Five double-blind placebo-controlled trials, 3499 patients

  • Study 1 : At week 24, the treatment difference between PRALUENT and placebo in mean LDL-C percent change was -58% (p: <0.0001).
  • Study 2 : At week 12, the mean percent change from baseline in LDL-C was -45% with PRALUENT compared to 1% with placebo,
  • Study 3 & 4 : At week 12, the treatment difference between PRALUENT 75 mg Q2W and placebo in mean LDL-C percent change was -48%
  • Study 5 : At week 24, the mean percent change from baseline in LDL-C was -43% with PRALUENT and -7% with placebo, and the treatment difference between PRALUENT and placebo in mean LDL-C percent change was -36% (p- <0.0001).The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined

Safety : Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization) Injection site reactions. Overall safety comparable to placebo


ODOMZO (sonidegib  Novartis, East Hanover, NJ)

Smoothened (Smo) antagonist which inhibits the Hedgehog (Hh) signaling pathway.

 Indication: Locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.


Single study, n=194.

Objective Response rate 58% with 3 complete responses and 35 partial responses. 18% patients experienced subsequent disease progression with 4 of these 7 patients having maintained a response of 6 months or longer. The remaining 82% have ongoing responses ranging from to 1.9+ to 18.6+ months

 Safety: Most serious- Musculoskeletal adverse reactions. Other common adverse reactions including muscle spasms, alopecia, dysgeusia, fatigue, nausea, decreased weight, decreased appetite, myalgia, pain, and vomiting


TECHNIVIE (AbbVie Inc. North Chicago, IL)

Fixed-dose combination tablet containing ombitasvir (hepatitis C virus NS5A inhibitor), paritaprevir (hepatitis C virus NS3/4A protease inhibitor), and ritonavir (CYP3A inhibitor, inhibits CYP3A mediated metabolism of paritaprevir and therefore increases its systemic exposure) for oral administration.

 Indication : TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis


PEARL-1. N= 135, with chronic HCV genotype 4 infections without cirrhosis. Technivie with ribavirin vs Technivie without ribavirin. Sustained virologic responses after week 12: 100% for Technivie + ribavirin,  91 percent for technivie only.


Increased Risk of ALT Elevations requiring hepatic laboratory testing. Other reactions were Fatigue, Nausea, Insomnia, Pruritus, Skin reactions



Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication – Name Confusion

guidance_prop namesISSUE: Reports of confusion between the antidepressant BRINTELLIX and anti-coagulant BRILLINTA have resulted in the wrong medication being prescribed or dispensed.

RECOMMENDATION: Include generic (established) name i.e. vortioxetine or ticragrelor, in addition to the brand name

STORYLINE : FDA has established a fairly rigorous procedure for Proprietary Name assessment based on safety aspects to reduce medication errors, and promotional implications that has helped reduce medication errors. Learnings from this latest report will be important in updating review standards.


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