Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Astrazeneca plc (London) |
Anifrolumab |
Formerly MDX-1333 |
Moderately to severely active systemic lupus erythematosus |
Phase IIb data showed it reduced disease activity compared with placebo across multiple endpoints |
11/6/15 |
Astrazeneca plc (London) |
Lesinurad |
A selective uric acid reabsorption inhibitor |
Hyperuricemia associated with gout |
Positive subanalysis data of the phase III studies (CLEAR1, CLEAR2 and CRYSTAL), in combination with a xanthine oxidase inhibitor, demonstrated a consistent efficacy and safety profile in patients with normal renal function |
11/10/15 |
Bristol-Myers Suibb Co. (New York) |
Orencia |
Abatacept |
Rheumatoid arthritis |
Phase III data showed that re-treatment with Orencia plus methotrexate can effectively recapture prior remission following flare after complete withdrawal of therapy |
11/9/15 |
Glaxosmithkline plc (London) |
Benlysta |
Belimumab |
Systemic lupus erythematosus |
Pivotal phase III BLISS-SC results showed that 60.8% of patients treated with belimumab 200 mg, administered weekly via subcutaneous injection plus standard of care, had reduced disease activity compared to placebo plus SoC (48.47%, p=0.0011) |
11/12/15 |
CANCER | |||||
Astrazeneca plc (London) |
Targrisso |
AZD9291 (osimertinib); once-daily oral therapy |
Metastatic EGFR T790M mutation-positive non-small-cell lung cancer |
Gained accelerated approval from the FDA |
11/16/15 |
Bavarian Nordic A/S (Copenhagen) |
MVA-BN Brachyury |
MVA-BN-based vaccine targeting brachyury - a tumor-associated antigen |
Cancer |
Phase I data showed that at the two highest dose levels tested, about 80% of the patients who developed brachyury-specific T cells demonstrated responses in both CD4 and CD8 T lymphocytes; the vaccine was found to be well tolerated, with no dose-limiting toxicities; the maximal tolerated dose was not reached |
11/4/15 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
BI 1482694 |
HM61713 |
T790M mutation-positive non-small-cell lung cancer |
Initiated a pivotal global phase II trial in patients whose tumors stopped responding to currently available epidermal growth factor receptor, or EGFR-directed, therapies |
11/4/15 |
Bristol-Myers Squibb Co. (New York) |
Opdivo |
Nivolumab |
Advanced renal cell carcinoma |
FDA has accepted for filing and granted priority review to a supplemental BLA for patients who have received prior anti-angiogenic therapy; FDA approved it |
11/18/15; 11/24/15 |
Bristol-Myers Squibb Co. (New York) |
Opdivo |
Nivolumab |
Treatment-naïve BRAF wild-type advanced melanoma |
Long-term data from Checkmate-066 showed Opdivo continued to demonstrate superior overall survival vs. dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine |
11/19/15 |
Bristol-Myers Squibb Co. (New York) |
Opdivo |
Nivolumab |
Metastatic melanoma |
FDA approved Opdivo injection, for intravenous use as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or MM. The approval is based on data from the phase III trial, Checkmate -066, which evaluated overall survival as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine) |
11/25/15 |
Debiopharm International SA (Lausanne, Switzerland) |
Debio 1143 |
A small-molecule inhibitor of IAPs |
Squamous cell carcinoma of the head and neck |
Achieved a recommended dose in two phase I studies; showed a favorable safety profile in a dose-finding and efficacy phase I/II trial in combination with chemoradiotherapy |
11/4/15 |
Debiopharm International SA (Lausanne, Switzerland) and Yakult Honsha Co. Ltd. (Tokyo) |
Elplat |
Oxaliplatin |
Gastric cancer |
Obtained approval for a supplemental NDA for Elplat in postoperative adjuvant chemotherapy |
11/25/15 |
Eli Lilly and Co. (Indianapolis) |
Portrazza |
Necitumumab |
Non-small-cell lung cancer |
FDA cleared it in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous NSCLC who have not previously received medication for their later-stage disease |
11/25/15 |
Glaxosmithkline plc (London) and Merck & Co. Inc. (Kenilworth, N.J.) |
GSK3174998 |
Immunotherapy; humanized immunoglobin G1 anti-OX40 monoclonal antibody |
Locally advanced, recurrent or metastatic solid tumors |
Initiated a phase I trial for its use as a monotherapy and in combination with Merck's anti-PD-1 therapy, Keytruda (pembrolizumab) |
11/4/15 |
Innate Pharma SA (Marseille, France) |
Lirilumab |
First-in-class checkpoint inhibitor, fully human monoclonal antibody |
Myelodysplastic syndrome |
Started a new trial testing a combination of Opdivo (nivolumab, Bristol-Myers Squibb Co.), lirilumab and Vidaza (5-azacytidine, Celgene Corp.) |
11/13/15 |
Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson) |
Imbruvica |
Ibrutinib; Bruton's kinase inhibitor |
Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma |
Submitted a supplemental NDA based on results form the phase III HELIOS trial testing Imbruvica in combination with bendamustine and Rituxan (rituximab, Biogen Inc. and Roche AG) vs. placebo plus bendamustine, Rituxan |
11/16/15 |
Janssen Inc. (Toronto) |
Daratumumab |
Human anti-CD38 monoclonal antibody |
Multiple myeloma |
Health Canada accepted for review the new drug submission |
11/19/15 |
Janssen-Cilag International NV (Beerse, Belgium) |
Imbruvica |
Ibrutinib |
Chronic lymphocytic leukemia |
Submitted a type II variation application to the EMA seeking to broaden the existing marketing authorization for Imbruvica to include previously untreated patients with chronic lymphocytic leukemia |
11/4/15 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; anti-PD-1 therapy |
Microsatellite instability high metastatic colorectal cancer |
FDA has granted breakthrough therapy designation |
11/3/15 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; anti-PD-1 therapy |
Advanced melanoma |
KEYNOTE-037 phase I/II data of Keytruda in combination with epacadostat showed that in 19 patients, the combination demonstrated an overall response rate of 53%, including three complete responses and seven partial responses; MASTERKEY-265 phase Ib data of Keytruda in combination with Imlygic showed that in 16 evaluable patients the combination resulted in an unconfirmed ORR of 56.3%, including two CRs and seven PRs; KEYNOTE-029 phase I/II data of 72 evaluable patients showed the combination of Keytruda and ipilimumab demonstrated an ORR of 56%, including three CRs and 37 PRs |
11/24/15 |
Merck KGaA (Darmstadt, Germany) and Pfizer Inc. (New York) |
Avelumab |
A fully human anti-PD-L1 IgG1 monoclonal antibody |
Treatment-naïve advanced non-small-cell lung cancer |
Started an international phase III trial called JAVELIN Lung 100, comparing avelumab with platinum-based doublet chemotherapy |
11/5/15 |
Merck KGaA (Darmstadt, Germany) and Pfizer Inc. (New York) |
Avelumab |
A fully human anti-PD-L1 IgG1 monoclonal antibody |
Metastatic Merkel cell carcinoma |
FDA granted breakthrough therapy designation; EMA's CHMP has issued a positive opinion for orphan drug designation |
11/19/15 |
Novartis AG (Basel, Switzerland) |
Biosimilar pegfilgrastim |
Biosimilar Neulasta (Amgen Inc.) |
Non-myeloid cancer |
FDA accepted its BLA |
11/19/15 |
Pfizer Inc. (New York) |
Xalkori |
Crizotinib |
Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer |
PROFILE 1029, its phase III study, met its primary objective of prolonging progression-free survival in previously untreated East Asian patients; European Commission approved a label update to expand its use to first-line treatment of adults |
11/19/15 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Ninlaro |
Ixazomib; an oral proteasome inhibitor |
Multiple myeloma |
FDA approved it for use with Revlimid (lenalidomide) and dexamethasone to treat patients who have received at least one prior therapy |
11/23/15 |
CARDIOVASCULAR | |||||
Astrazeneca plc (London) |
Crestor |
Rosuvastatin calcium |
Heterozygous familial hyperchol-esterolemia |
FDA approved it in pediatric patients, ages 8 to 17 |
11/25/15 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Pradaxa |
Dabigatran etexilate mesylate |
Prophylaxis of deep venous thrombosis and pulmonary embolism |
FDA approved it for patients who have undergone hip replacement surgery |
11/24/15 |
Novartis AG (Basel, Switzerland) |
Entresto |
Sacubitril/valsartan |
Heart failure |
Data showed that 44% fewer heart failure patients with reduced ejection fraction who were treated with Entresto were readmitted to the hospital for heart failure and 36% fewer were readmitted for any cause within 30 days of discharge from a heart failure hospitalization compared to patients treated with ACE inhibitor enalapril |
11/12/15 |
Novartis AG (Basel, Switzerland) |
Entresto |
Sacubitril/valsartan |
Patients with symptomatic chronic heart failure with reduced ejection fraction |
Gained European Commission approval |
11/25/15 |
CENTRAL NERVOUS SYSTEM | |||||
Astellas Pharma Inc. (Tokyo) |
Qutenza |
Capsaicin 8% patch |
Peripheral neuropathic pain |
Data from a head-to-head noninferiority study, ELEVATE, with 559 adults, comparing Qutenza with pregabalin capsules concluded that Qutenza provided noninferior pain relief vs. pregabalin and demonstrated a shorter median time to pain relief, fewer systemic side effects and greater treatment satisfaction |
11/20/15 |
Impax Laboratories Inc. (Hayward, Calif.) |
Numient |
Levodopa and carbidopa; a modified-release oral capsule formulation |
Parkinson's disease |
European Commission granted marketing authorization |
11/30/15 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Bridion |
Sugammadex; selective relaxant binding agents |
To reverse the neuromuscular blockade induced by rocuronium or vecuronium |
FDA committee unanimously endorsed approval of the NDA |
11/9/15 |
Pfizer Inc. (New York) |
Lyrica |
Pregabalin capsules |
Chronic post-traumatic peripheral neuropathic pain |
Top-line phase III data showed it did not meet its primary efficacy endpoint |
11/30/15 |
DIABETES | |||||
Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Conn.; part of Boehringer Ingelheim GmbH) and Eli Lilly and Co. (Indianapolis) |
Jardiance |
Empagliflozin |
Type 2 diabetes |
The reduction in risk for hospitalization for heart failure or cardiovascular death with Jardiance compared with placebo when added to standard of care was consistent across all subgroups analyzed |
11/10/15 |
Janssen Research & Development LLC (Raritan, N.J.; part of Johnson & Johnson) |
Invokamet XR |
The first fixed-dose combination tablet combining canagliflozin and immediate-release metformin hydrochloride |
Type 2 diabetes |
Submitted an NDA for Invokamet XR |
11/23/15 |
INFECTION | |||||
Novartis Vaccines and Diagnostics Ltd. (Cambridge, Mass.; unit of Novartis AG) |
Fluad |
Seasonal influenza vaccine |
Influenza |
Received FDA approval for Fluad |
11/30/15 |
Eli Lilly and Co. (Indianapolis) |
Ixekizumab |
An anti-IL-17 monoclonal antibody |
Psoriatic arthritis |
Phase III data showed it achieved significant improvements in signs and symptoms of their disease compared to placebo |
11/10/15 |
Novartis AG (Basel, Switzerland) |
Cosentyx |
Secukinumab |
Ankylosing spondylitis and psoriatic arthritis |
European Commission (EC) approved it |
11/24/15 |
MISCELLANEOUS | |||||
Teva Pharmaceutical Industries Ltd. (Petah Tikva, Israel) |
SD-809 |
Deutetrabenazine |
Moderate to severe tardive dyskinesia |
FDA granted breakthrough therapy designation |
11/10/15 |
RESPIRATORY | |||||
Glaxosmithkline plc (London) |
Nucala |
Mepolizumab |
Asthma |
FDA approved it as an add-on maintenance therapy for patients who have a history of severe asthma attacks despite being on treatment and who have an eosinophilic phenotype |
11/6/15 |
Teva Pharmaceutical Industries Ltd. (Petah Tikva, Israel) |
Fluticasone propionate/salmeterol |
A combination inhaled corticosteroid and long-acting beta agonist delivered via a multidose dry powder inhaler and fluticasone propionate |
Asthma |
Top-line results from three phase III studies showed they met their primary endpoints and showed similar overall safety profiles as compared to therapies in the corresponding drug classes |
11/20/15 |
|
Notes BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. For more information about individual companies and/or products, see Thomson Reuters Cortellis. | |||||