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Ever-changing Landscape of
Products on the Market
By Kyle McKendall, staff writer
For the past five years the bleeding removed in 2018. Takeda reported that the decision to
disorders community saw three discontinue BEBULIN production was based on reduced
or more products each year approved demand and was not connected with any new safety or efficacy
for treatment by the U.S. Food and findings.
Drug Administration.
In the year ahead, it is inevitable that the community will
In 2018, the seemingly never-ending growth slowed with continue to see changes to the list of products available,
just one new product being approved by the FDA - Bayer’s some of which we already know are coming. CSL Behring will
Jivi, a PEGylated recombinant clotting factor to treat VIII. see two products removed from the market and off our lists:
Genentech’s HEMLIBRA, a therapeutic bi-specific antibody Monoclate-P and Helixate FS. In March of 2018, CSL announced
factor, which had received FDA approval in 2017 for use in their decision to discontinue Monoclate-P due to their inability
hemophilia A patients with inhibitors, received FDA approval to sustain production and distribution amidst changes in the
for treatment of adults and children with hemophilia A, with or market. The company estimated that supplies will be available
without inhibitors. through the end of 2018, though supply is lasting into early
2019.
BEBULIN, a plasma-derived product to treat factor IX from
Takeda (the new name for Shire, as of January 2019), was While Helixate FS was a product offered by CSL Behring, it was
discontinued, so the factor IX product list saw one product actually manufactured by Bayer and supplied to CSL Behring
through a supply agreement which ended on Dec. 31, 2017.
Bayer’s product, Kogenate FS, and Helixate FS contain the
same active pharmaceutical ingredient and formulation and
were manufactured by Bayer in the same facility. Supplies of
Helixate FS will remain available through early 2019.
With a total of 43 products on the market, people living with
a bleeding disorder have access to more treatments than ever
before. Understanding all of the products that are available can
be challenging for any patient or caregiver, regardless of their
comfort level navigating the available options. To help with this
process, we’ve compiled a comprehensive list of all bleeding
disorder therapies on the market. S
Information in this issue of Dateline should not be interpreted as
medical advice. HFA encourages frequent dialogue with experienced
healthcare professionals regarding your health and the therapies
used to treat your bleeding disorder.
8 Dateline Federation | Special Issue 2018-19
