Answers
03/24/1995

<TITLE>RHo(D) IMMUNE GLOBULIN INTRAVENOUS LICENSED </TITLE>
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T95-17                                            Monica Revelle
March 24, 1995                                    (301) 443-4177

          RHo(D) IMMUNE GLOBULIN INTRAVENOUS LICENSED 

     FDA has been receiving inquiries about the recent approval of
a new product, Rho(D) Immune Globulin Intravenous (Human) (RhIGIV),
which is indicated to suppress Rho(D) sensitization of Rh negative
pregnant women and to treat an uncommon immune bleeding disorder,
idiopathic thrombocytopenic purpura (ITP).  The following can be
used to answer questions.
     RhIGIV is the only U.S. licensed anti-Rho(D) immune globulin
that can be administered intravenously.  The product also can be
given intramuscularly.  In addition, RhIGIV can be used at lower
doses than other non-specific intravenous immune globulins to treat
ITP in Rho(D) positive patients.
     RhIGIV has been found safe and effective in the suppression of
Rh sensitization in women who are at risk during pregnancy or at
delivery.  Adverse reactions include soreness at the injection
site, chills, fever and headache.  
     Maternal Rh isoimmunization, for which approximately 10
percent of pregnancies are at risk, occurs when an Rho(D) negative
mother is exposed to Rho(D) positive blood from her infant at
delivery.  When a women becomes Rh sensitized, the antibodies to 
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                                        T95-17, Page 2, Rho(D) IGIV
Rho(D) that develop will cause a severe disease (blue baby
syndrome) in future Rho(D) positive fetuses.
     RhIGIV is the first U.S. licensed product to suppress Rh
sensitization that incorporates a virus inactivation step in the
manufacturing process.  The inactivation step uses a solvent-
detergent method used in the manufacture of other injectable
products derived from blood.
     Although other currently marketed U.S. licensed intramuscular
immune globulin (IMIG) products used to suppress Rh sensitization
have not undergone viral inactivation, they have not been
implicated in transmission of any human diseases.  Nevertheless,
FDA has encouraged the inclusion of virus inactivation and/or
removal procedures in their manufacture as an added safeguard. 
Currently lots of IMIG are tested with polymerase chain reaction
(PCR) gene amplification methods for hepatitis C nucleic acid and
distributed if the results are negative.  FDA introduced this
procedure in December 1994 as an added safeguard because of
theoretical concerns about HCV transmission by these products.
     Excessive bleeding occurs with ITP when the number of
platelets, which play a major role in blood clotting, becomes
significantly less than one-tenth of normal.  This disorder affects
100,000 Americans  each year.  Clinical trials indicated that
RhIGIV was effective in treating children and adults with ITP,
including ITP associated with HIV infection.  RhIVIG can only be
used intravenously for the treatment of ITP.
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                                        T95-17, Page 3, Rho(D) IGIV
     FDA has granted orphan drug status for the use of RhIGIV in
the treatment of ITP.  Orphan drugs are drugs for rare diseases
affecting less than 200,000 Americans, or drugs for which a drug
company has no reasonable prospect of recovering research and
development costs.  To encourage development of such drugs, the
Orphan Drug Act, passed by Congress in 1983, gives companies a tax
advantage and a seven-year monopoly for marketing the orphan
product for the specific indication granted.
     RhIGIV is manufactured by Rh Pharmaceuticals Inc. of Winnipeg,
Manitoba, Canada, and distributed by Univax Biologics Inc. of
Rockville, Md., under the trade name WinRho SD.
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