AMAG FDA Approval of Feraheme [transcript] [audio]

Guest: Julie Krop, M.D.

Presenter: Neal Howard

Guest Bio: Julie Krop, M.D. serves as AMAG’s chief medical officer and senior vice president of clinical development and regulatory affairs. She joined AMAG in June 2015 and has more than 15 years of experience in drug development. Dr. Krop most recently worked for Vertex Pharmaceuticals, where she served as vice president of clinical development. She began her career in the biopharmaceutical industry in 1991 at Pfizer, Inc. and has since held various leadership positions at Stryker Regenerative Medicine, Peptimmune, and Millennium Pharmaceuticals. Dr. Krop received a Bachelor of Science degree from Brown University and a medical degree from the Brown University School of Medicine. She completed her residency in the Department of Medicine at Georgetown University Hospital and a fellowship in the Department of Endocrinology at The Johns Hopkins University School of Medicine. In addition, Dr. Krop was a Robert Wood Johnson Foundation Clinical Scholar.

Segment Overview: Dr. Julie Krop, AMAG’s Chief Medical Officer and Executive Vice President of Clinical and Regulatory Affairs discusses Feraheme® (ferumoxytol injection) that has recently been FDA approved for those patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron.

Transcript

Neal Howard: Hello and welcome to Health Professional Radio. I’m your host Neal Howard, glad that you could join us. Our guest today is Dr. Julie Krop. She’s AMAG Chief Medical Officer and Executive Vice President of Clinical and Regulatory Affairs and she’s joining us today to talk about Feraheme. It’s a newly FDA-approved application and I’ll let Dr. Krop tell us all about it. Welcome to the program Dr. Krop.

Dr. Julie Krop: Thank you so much. We’re very excited about our expanded approval. Iron deficiency anemia is a serious health condition that negatively impacts the quality of life and millions of people. And many of whom really cannot tolerate or benefit from oral iron therapy. So, before that approval, Feraheme was only approved for iron deficiency anemia due to chronic kidney disease but with this expanded approval, physicians now have the option to do that in a much broader population of patients with iron deficiency despite the etiology.

N: How many people are we talking about that are suffering from this IDA?

K: Currently in the United States are about four and a half million Americans today suffering from iron deficiency anemia. The symptoms are really common in nonspecific which is why it’s really an under-recognized condition. Oftentimes, patients will experience like diffuse body pain or fatigue. They are like early symptoms of the condition. They’re often ignored by those physicians and the patients because there’s some nonspecific in nature. Then if left untreated patients can go on to develop shortness of breath or palpitations and even pale skin and eyes which is commonly associated with anemia. It is an important health condition.

N: Who’s more at risk? Are men and women equally at risk or does the condition affect one more than the other?

K: Yes, that’s a really good question. Interestingly 20% of women experience or suffer from anemia at some point in their life compared to the only two percent of men. It is definitely more common in women and of course women have chronic blood loss due to monthly menstrual periods. If diet is not adequate they can certainly become anemic. In fact in our Phase III clinical trials we saw significant proportion of our patients who have abnormal uterine bleeding as the cause of their anemia. Of course also women from childbirth can potentially have blood loss as well as an output for iron deficiency anemia.

N: Your Chief Medical Officer and the Executive Vice President of clinical and regulatory affairs at AMAG. You’ve recently got some FDA approval for this Feraheme. Talk about the AMAG, many of our listeners may not be familiar with AMAG Pharmaceuticals.

K: Yes, absolutely. AMAG is a biopharmaceutical company where our headquarters here in Waltham, Massachusetts which is right outside Boston. We’re really focused on bringing novel therapies to market that help address important unmet needs for patients who are struggling oftentimes with under recognized conditions. We’re highly focused on maternal and women’s health. In the last year, we’ve really expanded our portfolio with the new therapies to address unmet medical needs and women really across their lifespan including menopause. So innovation in women’s health, we think is lagged behind other therapeutic areas and it’s really a top priority for us at AMAG. Also given our strong interest in women’s health and our large women’s health salesforce, we hopefully plan to leverage our capabilities to help serve the women that are in need with iron deficiency anemia.

N: Where there is some unexpected benefits that were discovered in getting FDA approval for Feraheme?

K: Yes. We have really exciting data. We had to had study comparing of Feraheme and a non-inferiority trial to one of our main competitors Injectafer. What we thought was the non-inferiority with regards to the rare safety events of hypersensitivity allergic responses. But importantly we discovered something that was quite interesting which is a very high degree or high percentage of patients developing hypophosphatemia which is low phosphate levels on the injector forearm compared to the Feraheme on. That was a really nice positive for us showing that hypophosphatemia can be a serious condition especially chronically can cause weakness and fatigue and can also cause long-term that can cause osteomalacia, another severe bone defects. It’s really important finding, I think.

N: If a condition is determined to be a rare disease as opposed to under-recognized disease, are those one in the same or is awareness a little bit less for an under-recognized as opposed to a rare? Because I know there’s a cost that seem to trickle down to the patient based on the rarity of a condition.

K: Absolutely. It’s a very good point. In drug development in rare diseases we often call them orphan drug conditions. Those are oftentimes not under recognized. They are just a few, small in number. They are from the frequency standpoint. But under recognized conditions can be quite common. For example, iron deficiency anemia, it’s quite common unfortunately it’s under recognized as I mentioned because of a non specific nature of the symptoms and so because it is a common condition. You’re right. It’s typically much greater a number and it’s less costly, hopefully to better institute for patients to get their therapies.

N: Would that cost also will be reflected in how the caregivers are given access to this new drug?

K: Yes, absolutely. Oftentimes there’s definitely greater hurdles. The more expensive a drug is so often conditions often have a lot more hurdles to get through in terms for insurers, in order for providers to get access to the therapy.

N: What are some other areas of innovation that you see emerging in women’s health and how is AMAG going to be at the forefront of some of those developments?

K: That’s a great question. We have a couple of novel and really innovative therapies here at AMAG in the women’s health space. The first is INTRAROSA, which was approved and launched this past year. INTRAROSA contains prasterone which is the DHEA, which is an inert hormone that’s locally converted in the vagina into estrogen and androgen and that’s really for the treatment of dysphoria due to vulva vaginal atrophy which is a common condition associated with menopause. In fact 50% of women suffer from DBA during menopause. INTRAROSA is the first non estrogen product for the treatment of this condition and it really offers women an exciting new therapeutic option that doesn’t contain the FDA black box warning label, that’s required by all estrogen products. We’re very excited about that product. We’re also really excited about one of our other products in later-stage development. In fact, we plan to submit a new drug application later this quarter for a peptide therapy with a novel mechanism of action to treat premenopausal women with a condition called hypo sexual desire disorder. And basically what that is, is unexplained low libido and associated distress after ruling out all other medical issues or causes that could cause low libido. This disorder affects approximately 10% of women and really negatively impacts not only their self-image but also significantly affects their relationships. It’s really exciting times I think for women and certainly for us here at AMAG.

N: Dr. Krop, where can our listeners go and learn more about Feraheme and about AMAG as well?

K: Yes. We have a Feraheme website www.feraheme.com and the AMAG company website is www.amagpharma.com.

N: Thank you so much. It’s been a pleasure.

K: It’s been a pleasure. Thank you so much.

N: You’ve been listening to Health Professional Radio. I’m your host Neal Howard. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm. You can subscribe to the podcast on iTunes, listen in and download at Soundcloud and be sure to visit our affiliate’s page at healthprofessionalradio.com.au.

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