HORIZON LINES: A QUARTERLY REVIEW OF NDAs
and Otezla. Spiriva Respimat was available as an inhalation powder. A new formulation for an inhalation spray was approved this quarter. Similarly, Abilify Maintena is now available as dual-chamber syringe. It was approved as a powder for suspension for injection. Beleodaq, Cerdelga, Keytruda, and Zydelig were among the novel new drugs for treating rare diseases. Zydelig is used to treat a total of 3 different types of cancers. Beleodaq and Zydelig received fast track approvals by FDA as these drugs have a potential to address unmet medical needs. Keytruda along with the Beleodaq and Zydelig got accelerated approvals in this quarter. Belsomra, Kerydin, Keytruda, Otezla, and Zydelig were First-in- Class drugs approved in this quarter. Breakthrough therapies are those where the drug with preliminary clinical evidence demonstrating that the drug may result in substantial improvement on at least 1 clinically
Approval date (2014)
July 3 July 7 July 11 July 16 July 22 July 23 July 23 July 25 July 28 July 29 July 31 August 1 August 1 August 6 August 8 August 13 August 14 Trade Name Beleodaq Kerydin* Rasuvo Ruconest Ryanodex Zydelig* Targiniq ER Acticlate Imbruvica Eylea
Striverdi Respimat
Jardiance Lumizyme Orbactiv Invokamet Belsomra* Avastin Drug Name Belinostat Tavaborole Methotrexate Conestat Alfa Dantrolene Sodium Idelalisib Naloxone and Oxycodone Doxycycline hyclate Ibrutinib Aflibercept Olodaterol Empagliflozin Alglucosidase alfa Oritavancin
Canagliflozin and metformin
Suvorexant Bevacizumab Dosage Form
Lyophilized powder for injection
Topical solution
Subcutaneous ready-to-use
autopen injection
Lyophilized powder for injection (iv)
Injectable suspension
Tablets
Extended release tablets
Tablets Capsules Injection (eye) Inhalation spray Tablets Injection IV injection Tablet Tablet IV injection
Salix Pharma and Pharming Group NV
Eagle Pharmaceuticals Inc.
Gilead Sciences, Inc. Purdue Pharma L.P.
Aqua Pharmaceuticals, LLC
Janssen Biotech Inc. & Pharmacyclics Inc.
Pharmaceuticals, Inc. Age-related macular degeneration Regeneron
Boehringer Ingelheim Pharmaceuticals Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
Genzyme Corporation
The Medicines Company
Janssen Research & Development, LLC
Merck, Sharpe & Dohme Corp.
Genentech, Inc. Pharmaceutical Outsourcing | 60 | March/April 2015
Chronic obstructive pulmonary disease
Type 2 diabetes Pompe disease
(patients of all ages) Skin and structure infections Type 2 diabetes Insomnia Metastatic cervical cancer
significant endpoint over other available therapies. Keytruda and Zydelig were the 2 drugs considered as breakthrough therapies. FDA provides priority review (review in 6 months instead of the standard 10 months) to some drugs to potentially provide a significant advance in medical care. Beleodaq, Cerdelga, Keytruda, Orbactiv, and Zydelig obtained a priority review. Under the GAIN (Generating Antibiotics Incentives Now) Act, incentives are provided to bring new antibiotics to the market. Under this, Orbactiv was designated as a Qualified Infectious Disease Product (QIDP) by the authority of the GAIN Act.
As for naming trends, a trend of including a few letters from the scientific drug name or company name was observed, as noted in Invokamet (combination of Canagliflozin & Metformin) or Kabiven (Company name Fresenius Kabi).
Company Spectrum
Pharmaceuticals Inc. Anacor
Pharmaceuticals Medac Pharma, Inc. Indication Peripheral T-cell lymphoma Onychomycosis of the toenails
Rheumatoid arthritis, poly-articular juvenile idiopathic arthritis
Acute angioedema attacks
Malignant hyperthermia Non-Hodgkin's lymphoma,
chronic lymphocytic leukemia, follicular lymphoma
Management of chronic severe pain Bacterial infection, acne Mantle cell lymphoma Price# $1550/vial (500 mg) $1250/bottle (10 ml) $470/package (4 auto injectors) N/A $2300/vial (250 mg) $7800/60 tablets N/A $690/30 tablets $91/capsules $1900/vial (0.05 ml) $168/inhaler $320/30 tablets $750/vial (50 mg) $1030/vial (400 mg) N/A $275/30 tablets $5547/2 vials
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