Page 10 - HFA Dateline 2019-2020 Special Issue

Changes in the Market

Treatment Options Down to 42 From 43 in 2019,

but 2020 Already Saw An Addition

By Kyle McKendall, staff writer

the 2019 calendar year came to a close, yet again As we were going to print with this issue in the first week
As the bleeding disorders community saw changes to of April 2020, HEMA Biologics garnered FDA approval for
the list of products approved for treatment by the U.S. Food SEVENFACT. The drug is a coagulation factor VIIa concentrate
and Drug Administration (FDA). indicated for the treatment and control of bleeding episodes
occurring in patients with hemophilia A or B with inhibitors.
While the year began with 43 products on the market,
the highest number ever, it ended lower at 42. The steady This product addition brings the total number of products
release of three or more products each year from 2013-2017 indicated for patients with inhibitors to four, and the total
that was slowed to just one product in 2018, was again not number of products on the market back up to 43.
seen: just one new product was released to market in 2019. What else does 2020 have in store for us? It’s hard to say
In February, the FDA approved Novo Nordisk’s ESPEROCT exactly, but when looking at the list of emerging therapies
(turoctocog alfa pegol) to treat and control bleeding in adults currently undergoing clinical trial (pg. 37), the possibilities
and children with hemophilia A. This brings Novo Nordisk’s seem endless. Our list contains 48 clinical trials from 21
number of products on the market up to five. sponsor companies. And, while gene therapy seems to be
everyone’s most talked about topic, it’s interesting to note that
As expected and reported in the 2018 version of this issue,
we saw two products removed from our lists in 2019: CSL 44% of the trials currently underway are for investigational
Behring’s Monoclate-P and Helixate FS. In March of 2018, factor therapies and 17% for novel therapies. However, you’ll
CSL Behring announced their decision to discontinue also see 19 gene therapy trials on our list, amounting to
Monoclate-P due to their inability to sustain production and 40% of all trials: a promising sign that change is coming.
distribution amidst changes in the market. Supply lasted into Understanding all the products that are available can be
early 2019. challenging for any patient or caregiver, regardless of their
comfort level navigating the available options. To help with
While Helixate FS was a product offered by CSL Behring, it
was actually manufactured by Bayer and supplied to CSL this process, we’ve compiled a comprehensive list of all
Behring through a supply agreement which ended on Dec. 31, bleeding disorder therapies approved and on the market.
2017. Bayer’s product, Kogenate FS, and Helixate FS contain Information in this issue of Dateline should not be interpreted
the same active pharmaceutical ingredient and formulation as medical advice. HFA encourage frequent dialogue with
and were manufactured by Bayer in the same facility. experienced healthcare professionals regarding your health
Supplies of Helixate FS remained available through early and the therapies used to treat your bleeding disorder. S
2019. The removal of these products brings CSL Behring’s
number of products on the market down to seven.

Information in this issue of Dateline should not be interpreted as medical advice. HFA encourage frequent dialogue with experienced healthcare
professionals regarding your health and the therapies used to treat your bleeding disorder.

10 HEMOPHILIA FEDERATION OF AMERICA < www.hemophiliafed.org