Monday, October 19, 2020

Regeneron's Antibody Cocktail Against COVID-19 Virus Shows Promising Results

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In this Issue

•  IVIG/Albumin Supply Index
•  Open Market Pricing
•  New Products from FFF
•  Current Medicare
IVIG / SCIG Rates
•  Resources
•  Subscribe to IG Living and BioSupply Trends Quarterly
 

A study shows Regeneron's antibody cocktail reduces levels of the COVID-19 virus and improves symptoms in patients, with the greatest improvements seen in patients who haven't already mounted a natural response to the infection. The treatment also showed positive trends at reducing medical visits for patients, none of whom were sick enough to be hospitalized at the start of the trial. read more ]

Preventive Nasal Spray Reduces COVID-19 Virus Levels

Test results from a gold-standard animal study show a novel nasal treatment, INNA-051, being developed by Australian biotech company Ena Respiratory, reduced COVID-19 viral replication by up to 96 percent. INNA-051 works by stimulating the innate immune system, and study results provide evidence it can be used as a stand-alone method of antiviral preventive therapy, complementary to vaccine programs. read more ]

FDA Released New Guidelines for COVID-19 Vaccine Developers

The U.S. Food and Drug Administration has released new guidelines for COVID-19 vaccine developers that call for gathering comprehensive safety data in the final stage of clinical trials before an emergency authorization can be granted. Among the recommendations, the agency advised vaccine makers to follow volunteers for a median of two months after the final dose. FDA also expects vaccine makers to document five cases of severe infection in people who received the placebo instead of the vaccine. read more ]

Industry News

 
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From CSL Behring

The U.S. Food and Drug Administration has approved CSL Behring's Haegarda (C1 esterase inhibitor subcutaneous [human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older. Haegarda is now the first and only subcutaneous treatment option for prevention of HAE attacks in these patients. In addition to the expanded pediatric indication, the updated label now includes clinical safety data regarding Haegarda use in pregnant women. read more ]

From Grifols

Grifols has entered into a transaction to acquire Alkahest to identify innovative therapies for age-related diseases. Alkahest has developed a map of the human plasma proteome facilitating the identification of plasma proteins and their recombinant analogues as potential therapeutic medicines. The company has four candidates in six Phase II clinical trials covering therapeutic products for neurodegenerative, cognitive decline, neuromuscular and ophthalmic indications.  [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

IXINITY (APTEVO BIOTHERAPEUTICS)

IXINITY (coagulation factor IX [recombinant]) is a human blood coagulation factor indicated for adults and children 12 years and older with hemophilia B for control and prevention of bleeding episodes and perioperative management. It is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). Kits include one single-use vial (containing nominally 250, 500, 1000, 1500, 2000 and 3000 IU per vial), a 10 mL syringe prefilled with 5 mL of sterile water for injection with plunger rod attached, and a vial adapter with filter.

For more information about IXINITY, log in to biosupply.fffenterprises.com

ONDANSETRON (INTAS PHARMACEUTICALS)

ONDANSETRON injection USP is a 5-HT receptor antagonist indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy and prevention of postoperative nausea and/or vomiting. It is supplied in 2-mL single-dose vials and 20-mL multidose vials (singles).

For more information about ONDANSETRON, log in to biosupply.fffenterprises.com

STERILE WATER (WEST-WARD PHARMACEUTICALS)

STERILE WATER for injection is a sterile nonpyrogenic preparation of water that contains no bacteriostat, antimicrobial agent or added buffer designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. It is supplied only in single-dose containers to dilute or dissolve drugs for injection.

For more information about STERILE WATER, log in to biosupply.fffenterprises.com

AMIODARONE HYDROCHLORIDE (WEST-WARD PHARMACEUTICALS)

AMIODARONE HYDROCHLORIDE injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. The 50 mg/mL injection dosage is supplied in 3 mL single-dose vials in cartons of 10 and 25.

For more information about AMIODARONE HYDROCHLORIDE, log in to biosupply.fffenterprises.com

ANAVIP (RARE DISEASE THERAPEUTICS)

ANAVIP [Crotalidae Immune F(ab')2 (Equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. It is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay. Each carton contains 1 vial of ANAVIP.

For more information about ANAVIP, log in to biosupply.fffenterprises.com

HIZENTRA PRE-FILLED SYRINGES (CSL BEHRING)

HIZENTRA (immune globulin subcutaneous [human] 20% liquid) PRE-FILLED SYRINGES for primary immunodeficiency patients are ready to use, eliminating the need to transfer the drug from the vial to a syringe. The syringes come in 5 mL and 10 mL (fully assembled) and 20 mL (requiring the plunger rod to be screwed onto the syringe stopper prior to use).

For more information about HIZENTRA PRE-FILLED SYRINGES, log in to biosupply.fffenterprises.com

ALBUMINEX 5% (BIO PRODUCTS LABORATORY)

ALBUMINEX 5% is a 5% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 5 g/dL clear type II glass vials.

For more information about ALBUMINEX 5%, log in to biosupply.fffenterprises.com

ALBUMINEX 25% (BIO PRODUCTS LABORATORY)

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 25 g/dL clear type II glass vials.

For more information about ALBUMINEX 25%, log in to biosupply.fffenterprises.com

TYMLOS  (RADIUS HEALTH)

TYMLOS (abaloparatide) injection, for subcutaneous use, is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It is supplied in a glass cartridge containing 3,120 mcg of abaloparatide in 1.56 mL of sterilized, clear, colorless fluid as a pre-assembled single-patient-use disposable pen packaged in a cardboard carton. Each pen provides a 30-day supply for once-daily injection of 80 mcg abaloparatide in 40 mcL. Sterile needles are not included.

For more information about TYMLOS, log in to biosupply.fffenterprises.com

These products can be ordered from FFF Enterprise's BioSupply Online Ordering System or by calling
Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective Oct. 1, 2020, through Dec. 31, 2020.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
FLEBOGAMMA J1572 $80.77 $79.47
GAMMAGARD SD J1566 $136.61 $134.42
GAMMAPLEX J1557 $107.32 $105.60
OCTAGAM J1568 $82.46 $81.14
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $83.01 $81.67
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $140.22 $137.97
HIZENTRA J1559 $108.55 $106.81
HYQVIA J1575 $144.86 $142.54
XEMBIFY J1558 $142.23 $139.95
IVIG / SCIG
GAMMAGARD LIQUID J1569 $86.40 $85.02
GAMMAKED J1561 $84.37 $83.02
GAMUNEX-C J1561 $84.37 $83.02

* Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
** ASP-based Medicare payment rate not yet available; payment rate assigned by your Medicare Administrative Contractor.

 

Resources

FFF customers may order the following complementary resources to help you with your practice:

•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

Subscribe to IG Living

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Trends Quarterly

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