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Monthly News Roundup - January 2019

Tosymra (sumatriptan) Nasal Spray Cleared for Acute Migraine Treatment

Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) now approved for the acute treatment of migraine with or without aura in adults.

  • In a migraine with aura, sensory disturbances including vision changes such as flashes of light or blind spots and tingling in the hand or face may occur.
  • Tosymra, from Dr. Reddy’s Laboratories and Promius Pharma, is a mist-like nasal spray formulated using a proprietary drug delivery technology that enhances absorption and leads to rapid action and blood levels comparable to the injected formulation of sumatriptan.
  • Common side effects of Tosymra may include dizziness, tingling, feeling warm, pressure or tightness sensation, nasal application reactions, abnormal taste, and throat irritation, among others.

Ontruzant (trastuzumab-dttb) Approved as Third Biosimilar to Herceptin

The U.S Food and Drug Administration has approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a HER2/neu receptor antagonist biosimilar to Genentech’s Herceptin (trastuzumab).

  • Ontruzant is approved across all eligible indications, including certain types of HER2+ breast cancer or stomach cancer.
  • Expected side effects for Ontruzant include fever, nausea, vomiting, diarrhea, neutropenia, infection, cough, fatigue and anemia, among others.
  • Other marketed biosimilars for Herceptin include Ogivri (trastuzumab-dkst) from Mylan and Herzuma (trastuzumab-pkrb) from Celltrion/Teva. Herzuma did not gain approval for the stomach cancer indication.

First Generic Advair Diskus Now Approved for Asthma and COPD

As a late-breaker in January, the FDA cleared the first generic option for GlaxoSmithKline’s widely used Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler.

  • Mylan’s new generic is dosed twice-daily for treatment of asthma in patients aged four years and older and for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).
  • The generic will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.
  • The FDA continues to advance new policies to promote more generic competition for complex drugs and “combination products” that consist of a drug and a device.

Janssen’s Imbruvica OK’d for Non-Chemo Regimen in CLL and SLL

This month, the FDA approved Janssen's Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults.

  • Imbruvica is a once-daily, oral Bruton's tyrosine kinase (BTK) inhibitor. This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL.
  • In the phase 3 iLLUMINATE study ibrutinib plus obinutuzumab showed a significant improvement in progression-free survival when compared with the chlorambucil plus obinutuzumab regimen, with a 77% reduction in risk of disease progression or death.
  • Commonly reported side effects included neutropenia (48%), thrombocytopenia (36%), rash (36%), and diarrhea (34%), among others.

FDA Gives the Nod to Vaxelis, a 6-in-1 Peds Vaccine

The FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine).

  • Vaxelis, from Sanofi and Merck, is a hexavalent vaccine used to immunize children from 6 weeks through 4 years of age for prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.
  • The 3-dose immunization series consists of a 0.5 mL intramuscular (IM) injection, administered at 2, 4, and 6 months of age.
  • An additional dose of a pertussis-containing vaccine is needed to complete the primary immunization series against pertussis.
  • Hexavalent vaccines can provide protection against six diseases with just one shot at a time. Vaxelis will not be commercially available until 2020.

First Generic Version of Sabril Approved for Epilepsy

Overpriced medications in the U.S. are an ongoing reality. Yet, many drugs are off-patent but still have no generic version available, leaving patients paying the higher price. The FDA is attempting to quell this trend.

  • Teva’s first-time generic for Sabril (vigabatrin) has been approved for treating complex partial seizures as an adjunctive therapy in patients 10 years and older who have responded inadequately to other treatments.
  • Sabril was part of a longer list of off-patent, off-exclusivity branded drugs without approved generics the FDA has recently highlighted.
  • The FDA states they will continue to refine and update the list to highlight drugs that can be developed in generic forms to create significant cost-savings for patients.

Posted: January 2019